{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-30",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "58",
          "submission_status": "AP",
          "submission_status_date": "20060412",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "24925",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020406s058, 021281s017, 021428s006ltr.pdf",
              "date": "20060413",
              "type": "Letter"
            },
            {
              "id": "34614",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020406s058,021281s017,021428s006lbl.pdf",
              "date": "20060413",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "19970508",
          "review_priority": "UNKNOWN",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "64",
          "submission_status": "AP",
          "submission_status_date": "20070614",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12546",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020406s064,021281s021,021428s012lbl.pdf",
              "date": "20070627",
              "type": "Label"
            },
            {
              "id": "24926",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020406s064, 021281s021, 021428s012ltr.pdf",
              "date": "20070705",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "56",
          "submission_status": "AP",
          "submission_status_date": "20040615",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "2489",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20406slr056ltr.pdf",
              "date": "20040616",
              "type": "Letter"
            },
            {
              "id": "34613",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20406slr056_prevacid_lbl.pdf",
              "date": "20040616",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "48",
          "submission_status": "AP",
          "submission_status_date": "20021203",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "20649",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020406_S048_PREVACID.pdf",
              "date": "20071119",
              "type": "Review"
            },
            {
              "id": "24923",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20406slr048,21281slr004ltr.pdf",
              "date": "20021203",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "19960913",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "46",
          "submission_status": "AP",
          "submission_status_date": "20020307",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "19960130",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "20637",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020406_s006_Prevacid_Delayed_Release_Capsules.pdf",
              "date": "20090916",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "38",
          "submission_status": "AP",
          "submission_status_date": "20010501",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "24920",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20406S38ltr.pdf",
              "date": "20030731",
              "type": "Letter"
            },
            {
              "id": "34611",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20406s38lbl.pdf",
              "date": "20030424",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "52",
          "submission_status": "AP",
          "submission_status_date": "20020830",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "41352",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21428_20406s052_21281s007_PrevacidTOC.html",
              "date": "20050623",
              "type": "Review"
            },
            {
              "id": "12544",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21-428lbl.pdf",
              "date": "20020830",
              "type": "Label"
            },
            {
              "id": "2488",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21428,20406s052,21281s007ltr.pdf",
              "date": "20020830",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "19951018",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "20636",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020406_s004_Prevacid_Delayed_Release_Capsules.pdf",
              "date": "20090916",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "44",
          "submission_status": "AP",
          "submission_status_date": "20011205",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "20648",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020406_s044_Prevacid_Delayed_Release_Capsules.pdf",
              "date": "20090916",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "36",
          "submission_status": "AP",
          "submission_status_date": "19991115",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "19960408",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "28",
          "submission_status": "AP",
          "submission_status_date": "19990706",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "41348",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20406S016.html",
              "date": "19990706",
              "type": "Review"
            },
            {
              "id": "24918",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20406s28ltr.pdf",
              "date": "19990706",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "42",
          "submission_status": "AP",
          "submission_status_date": "20001208",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "95",
          "submission_status": "AP",
          "submission_status_date": "20230808",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "75022",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020406Orig1s095;021428Orig1s042ltr.pdf",
              "date": "20230809",
              "type": "Letter"
            },
            {
              "id": "75040",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020406s095,021428s042lbl.pdf",
              "date": "20230810",
              "type": "Label"
            },
            {
              "id": "75041",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020406s095,021428s042lbl.pdf#page=45",
              "date": "20230810",
              "type": "Medication Guide"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "34",
          "submission_status": "AP",
          "submission_status_date": "20000620",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "20645",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20406-S034_Prevacid.pdf",
              "date": "20000620",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "87",
          "submission_status": "AP",
          "submission_status_date": "20180607",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "54512",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s087s088,021428s034s035lbl.pdf",
              "date": "20180611",
              "type": "Label"
            },
            {
              "id": "54574",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020406Orig1s087, s088, 021428Orig1s034, s035ltr.pdf",
              "date": "20180614",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "19980319",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "20644",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020406_s026_Prevacid_Delayed_Release_Capsules.pdf",
              "date": "20090916",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "40",
          "submission_status": "AP",
          "submission_status_date": "20010507",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "79",
          "submission_status": "AP",
          "submission_status_date": "20120503",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "24929",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020406s079,021428s026ltr.pdf",
              "date": "20120509",
              "type": "Letter"
            },
            {
              "id": "34619",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020406s079,021428s026lbl.pdf",
              "date": "20120507",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "19970623",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "20638",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020406_s018_Prevacid_Delayed_Release_Capsules.pdf",
              "date": "20090916",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "32",
          "submission_status": "AP",
          "submission_status_date": "19991115",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19950510",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "41339",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020406_prevacid_toc.html",
              "date": "20100316",
              "type": "Review"
            },
            {
              "id": "63929",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020406_Lansoprazole_Tab_2_WR_8-26-99.pdf",
              "date": "19000101",
              "type": "Pediatric Written Request"
            },
            {
              "id": "63930",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020406--021281_Lansoprazole_Tab_3_Amend_12-31-01.pdf",
              "date": "19000101",
              "type": "Pediatric Amendment 1"
            },
            {
              "id": "68937",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20406s067_21281s024_21428s017_Lansoprazole (Prevacid) Clinical_BPCA.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "68938",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20406s067_21281s024_21428s017_Lansoprazole (Prevacid) Clinpharm_BPCA.pdf",
              "date": "19000101",
              "type": "Pediatric Clinical Pharmacology Review"
            },
            {
              "id": "68939",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20406s067_21281s024_21428s017_Lansoprazole (Prevacid) Statistical_BPCA.pdf",
              "date": "19000101",
              "type": "Pediatric Statistical Review"
            },
            {
              "id": "23580",
              "url": "http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm",
              "date": "20111220",
              "type": "Other Important Information from FDA"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "19980623",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "20643",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020406_s024_Prevacid_Delayed_Release_Capsules.pdf",
              "date": "20090916",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "77",
          "submission_status": "AP",
          "submission_status_date": "20110520",
          "review_priority": "901 REQUIRED",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "24928",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020406s077,021428s024ltr.pdf",
              "date": "20110525",
              "type": "Letter"
            },
            {
              "id": "34618",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s077,021428s024lbl.pdf",
              "date": "20110526",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "19980312",
          "review_priority": "UNKNOWN",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "41343",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20406S016.html",
              "date": "19980312",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "30",
          "submission_status": "AP",
          "submission_status_date": "19990222",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "41349",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20406-S030_Prevacid.pdf",
              "date": "19990222",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "83",
          "submission_status": "AP",
          "submission_status_date": "20171018",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "50100",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020406Orig1s083,021428Orig1s031ltr.pdf",
              "date": "20171019",
              "type": "Letter"
            },
            {
              "id": "50182",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020406s083,021428s031lbl.pdf",
              "date": "20171025",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "19980720",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "20641",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020406_S022_PREVACID.pdf",
              "date": "19980720",
              "type": "Review"
            },
            {
              "id": "2487",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20406S021ltr.pdf",
              "date": "19980720",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "75",
          "submission_status": "AP",
          "submission_status_date": "20110601",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "2496",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020406s075,021428s022ltr.pdf",
              "date": "20110603",
              "type": "Letter"
            },
            {
              "id": "34617",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s075,021428s022lbl.pdf",
              "date": "20110607",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "67",
          "submission_status": "AP",
          "submission_status_date": "20081028",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "52302",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020406_Lansoprazole_Tab_2_WR_8-26-99.pdf",
              "date": "20080715",
              "type": "Pediatric Written Request"
            },
            {
              "id": "52303",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020406, 021281_Lansoprazole_Tab_3_Amend_12-31-01.pdf",
              "date": "20080715",
              "type": "Pediatric Amendment 1"
            },
            {
              "id": "52304",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020406_Lansoprazole_Tab_5_Amend_12-18-02.pdf",
              "date": "20080715",
              "type": "Pediatric Amendment 3"
            },
            {
              "id": "52305",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020406, 021281_Lansoprozole_Tab_6_amend_9-6-05.pdf",
              "date": "20080715",
              "type": "Pediatric Amendment 4"
            },
            {
              "id": "52960",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020406_lansoprazole_Prevacid_6-18-02_HFD180_amend2.pdf",
              "date": "20080715",
              "type": "Pediatric Amendment 2"
            },
            {
              "id": "52961",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020406s057_lansoprazole_Prevacid-Med&ClinPharmRev.pdf",
              "date": "20080715",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "52962",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020406s057_lansoprazole_Prevacid-StatRev.pdf",
              "date": "20080715",
              "type": "Pediatric Statistical Review"
            },
            {
              "id": "52963",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20406s057_lansoprazole_Prevacid-ClinpharmRev.pdf",
              "date": "20080715",
              "type": "Pediatric Clinical Pharmacology Review"
            },
            {
              "id": "12547",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020406s067,021281s024,021428s017lbl.pdf",
              "date": "20081107",
              "type": "Label"
            },
            {
              "id": "2492",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020406s067, 021281s024, 021428s017ltr.pdf",
              "date": "20081029",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "81",
          "submission_status": "AP",
          "submission_status_date": "20141219",
          "review_priority": "901 REQUIRED",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "24931",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020406Orig1s081,021428Orig1s028ltr.pdf",
              "date": "20141224",
              "type": "Letter"
            },
            {
              "id": "34621",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021428s028lbl020406s081lbl.pdf",
              "date": "20141229",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "19970904",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "20639",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020406_s020_Prevacid_Delayed_Release_Capsules.pdf",
              "date": "20090916",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "73",
          "submission_status": "AP",
          "submission_status_date": "20100512",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "2494",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020406s073,021428s020ltr.pdf",
              "date": "20100517",
              "type": "Letter"
            },
            {
              "id": "34616",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020406s073,021428s020lbl.pdf",
              "date": "20100517",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "19961224",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "65",
          "submission_status": "AP",
          "submission_status_date": "20080421",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "2491",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021281s022, 020406s065, 021428s013ltr.pdf",
              "date": "20080423",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "57",
          "submission_status": "AP",
          "submission_status_date": "20040617",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "12545",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020406s057_021281s014_021428s004lbl%20.pdf",
              "date": "20041221",
              "type": "Label"
            },
            {
              "id": "2490",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20406se5-057,21281se8-014,21428se8-004ltr.pdf",
              "date": "20040623",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "71",
          "submission_status": "AP",
          "submission_status_date": "20090731",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "2493",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020406s071,021281s026,021428s019ltr.pdf",
              "date": "20091112",
              "type": "Letter"
            },
            {
              "id": "34615",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020406s071,021281s026,021428s019lbl.pdf",
              "date": "20090813",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "19970417",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "19970225",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "41342",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020406_s009_PrevacidDelayedReleaseCaps.pdf",
              "date": "20090916",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "55",
          "submission_status": "AP",
          "submission_status_date": "20030805",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "24924",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21428slr001,21281slr009,20406slr055ltr.pdf",
              "date": "20030815",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "47",
          "submission_status": "AP",
          "submission_status_date": "20020731",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "12543",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20406s47lbl.pdf",
              "date": "20020731",
              "type": "Label"
            },
            {
              "id": "24922",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20406se5-047LTR.pdf",
              "date": "20020731",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "19960725",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "41341",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020406_s007_Prevacid_Delayed_Release_Capsules.pdf",
              "date": "20090916",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "39",
          "submission_status": "AP",
          "submission_status_date": "20001030",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "20646",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020406_s039_Prevacid_Delayed_Release_Capsules.pdf",
              "date": "20090916",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "45",
          "submission_status": "AP",
          "submission_status_date": "20020503",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "24921",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20406s045and21281s002ltr.pdf",
              "date": "20020503",
              "type": "Letter"
            },
            {
              "id": "34612",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20406s45lbl.pdf",
              "date": "20020503",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "19960506",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "41340",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020406_s005_Prevacid_Delayed_Release_Capsules.pdf",
              "date": "20090916",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "29",
          "submission_status": "AP",
          "submission_status_date": "19981120",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "43",
          "submission_status": "AP",
          "submission_status_date": "20010411",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "41351",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020406_s043_Prevacid_Delayed_Release_Capsules.pdf",
              "date": "20090916",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "35",
          "submission_status": "AP",
          "submission_status_date": "20000602",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "41350",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020406_s035_Prevacid Caps.pdf",
              "date": "20090916",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "88",
          "submission_status": "AP",
          "submission_status_date": "20180607",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "54511",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s087s088,021428s034s035lbl.pdf",
              "date": "20180611",
              "type": "Label"
            },
            {
              "id": "54575",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020406Orig1s087, s088, 021428Orig1s034, s035ltr.pdf",
              "date": "20180614",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19951130",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "19990114",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "41347",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20406-S030_Prevacid.pdf",
              "date": "19990114",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "41",
          "submission_status": "AP",
          "submission_status_date": "20010629",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "20647",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020406_s041_Prevacid_Delayed_Release_Capsules.pdf",
              "date": "20090916",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "94",
          "submission_status": "AP",
          "submission_status_date": "20220304",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "70409",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020406Orig1s094; 021428Orig1s041ltr.pdf",
              "date": "20220307",
              "type": "Letter"
            },
            {
              "id": "70463",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020406s094,021428s041lbl.pdf",
              "date": "20220310",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "19970917",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "41345",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020406_s019_Prevacid_Delayed_Release_Capsules.pdf",
              "date": "20090916",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "33",
          "submission_status": "AP",
          "submission_status_date": "20001130",
          "review_priority": "UNKNOWN",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "24919",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20406S33ltr.pdf",
              "date": "20001130",
              "type": "Letter"
            },
            {
              "id": "34610",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20406S33lbl.pdf",
              "date": "20001130",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "19980727",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "41346",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020406_s025_Prevacid_Delayed_Release_Capsules.pdf",
              "date": "20090916",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "78",
          "submission_status": "AP",
          "submission_status_date": "20120928",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12550",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020406s078-021428s025lbl.pdf",
              "date": "20121001",
              "type": "Label"
            },
            {
              "id": "2497",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020406Orig1s078,021428Orig1s025ltr.pdf",
              "date": "20121002",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "92",
          "submission_status": "AP",
          "submission_status_date": "20201127",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "65374",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020406Orig1s092;021428Orig1s039ltr.pdf",
              "date": "20201130",
              "type": "Letter"
            },
            {
              "id": "65412",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020406s092,021428s039lbl.pdf",
              "date": "20201130",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "19970917",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "41344",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020406Orig1s017.pdf",
              "date": "20111209",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "84",
          "submission_status": "AP",
          "submission_status_date": "20180413",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "53696",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020406Orig1s084,021428Orig1s032ltr.pdf",
              "date": "20180416",
              "type": "Letter"
            },
            {
              "id": "53707",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s084,021428s032lbl.pdf",
              "date": "20180417",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "19980611",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "20642",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020406_s023_Prevacid_Delayed_Release_Capsules.pdf",
              "date": "20090916",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "76",
          "submission_status": "AP",
          "submission_status_date": "20111028",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12549",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s076,021428s023lbl.pdf",
              "date": "20111101",
              "type": "Label"
            },
            {
              "id": "24927",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020406s076ltr, 021428s023ltr.pdf",
              "date": "20111031",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "90",
          "submission_status": "AP",
          "submission_status_date": "20200911",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "64567",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020406Orig1s090, 021428Orig1s037ltr.pdf",
              "date": "20200914",
              "type": "Letter"
            },
            {
              "id": "64586",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020406s090,021428s037lbl.pdf",
              "date": "20200917",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "19970617",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "68",
          "submission_status": "AP",
          "submission_status_date": "20080908",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "82",
          "submission_status": "AP",
          "submission_status_date": "20161024",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "45664",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021428Orig1s030,020406Orig1s082ltr.pdf",
              "date": "20161026",
              "type": "Letter"
            },
            {
              "id": "45714",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020406s082,021428s030lbl.pdf",
              "date": "20161031",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "19980720",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "20640",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20406-s021.html",
              "date": "19980720",
              "type": "Review"
            },
            {
              "id": "24917",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20406S021ltr.pdf",
              "date": "19980720",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "74",
          "submission_status": "AP",
          "submission_status_date": "20100903",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12548",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020406s074,021428s021lbl.pdf",
              "date": "20100910",
              "type": "Label"
            },
            {
              "id": "2495",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020406s074,021428s021ltr.pdf",
              "date": "20100909",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "19970617",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "80",
          "submission_status": "AP",
          "submission_status_date": "20151216",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "34620",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020406s080-021428s027lbl.pdf",
              "date": "20151217",
              "type": "Label"
            },
            {
              "id": "24930",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020406Orig1s080;021428Orig1s027ltr.pdf",
              "date": "20151218",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA020406",
      "sponsor_name": "TAKEDA PHARMS USA",
      "openfda": {
        "application_number": [
          "NDA020406"
        ],
        "brand_name": [
          "PREVACID"
        ],
        "generic_name": [
          "LANSOPRAZOLE"
        ],
        "manufacturer_name": [
          "Takeda Pharmaceuticals America, Inc."
        ],
        "product_ndc": [
          "64764-046",
          "64764-543",
          "64764-544"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LANSOPRAZOLE"
        ],
        "rxcui": [
          "206205",
          "206206",
          "311277",
          "351260",
          "351261",
          "866152"
        ],
        "spl_id": [
          "45f1d5ff-d884-4e40-a16c-313a4e21e32c"
        ],
        "spl_set_id": [
          "71ba78cb-7e46-43eb-9425-fa130f537f84"
        ],
        "package_ndc": [
          "64764-046-13",
          "64764-046-19",
          "64764-046-11",
          "64764-046-06",
          "64764-543-30",
          "64764-543-11",
          "64764-543-05",
          "64764-544-30",
          "64764-544-11",
          "64764-544-05"
        ],
        "nui": [
          "N0000175525",
          "N0000000147",
          "N0000009724"
        ],
        "pharm_class_epc": [
          "Proton Pump Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Proton Pump Inhibitors [MoA]"
        ],
        "pharm_class_pe": [
          "Inhibition Gastric Acid Secretion [PE]"
        ],
        "unii": [
          "0K5C5T2QPG"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "PREVACID",
          "active_ingredients": [
            {
              "name": "LANSOPRAZOLE",
              "strength": "15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE, DELAYED REL PELLETS",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "PREVACID",
          "active_ingredients": [
            {
              "name": "LANSOPRAZOLE",
              "strength": "30MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "CAPSULE, DELAYED REL PELLETS",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}