{
  "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": "2026-07-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20020807",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "41497",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020632_S014_MERIDIA.pdf",
              "date": "20080219",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19971122",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "41495",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20632_meridia.html",
              "date": "20030617",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20041124",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "2917",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20632s019,020ltr.pdf",
              "date": "20041202",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20010216",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "2915",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20632S008011ltr.pdf",
              "date": "20010216",
              "type": "Letter"
            },
            {
              "id": "34990",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20632s8s11LBL.pdf",
              "date": "20010216",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "19991112",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "20778",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020632_S006_MERIDIA_CAPSULES.pdf",
              "date": "20080219",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "35",
          "submission_status": "AP",
          "submission_status_date": "20100804",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "23170",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035MedGuide.pdf",
              "date": "20100810",
              "type": "Medication Guide"
            },
            {
              "id": "25363",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020632s034,s035ltr.pdf",
              "date": "20100810",
              "type": "Letter"
            },
            {
              "id": "34997",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035lbl.pdf",
              "date": "20100810",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "19990706",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "41496",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020632_S004_MERIDA_CAPSULES.pdf",
              "date": "20080219",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20041124",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "12874",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20632s019,020lbl.pdf",
              "date": "20041203",
              "type": "Label"
            },
            {
              "id": "2916",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20632s019,020ltr.pdf",
              "date": "20041202",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "19980807",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "20777",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020632_S002_MERIDIA_CAPSULES.pdf",
              "date": "20080219",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20030925",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "41498",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020632_S017_MERIDIA_AP.pdf",
              "date": "20070709",
              "type": "Review"
            },
            {
              "id": "25359",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20632slr017ltr.pdf",
              "date": "20030930",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "31",
          "submission_status": "AP",
          "submission_status_date": "20081224",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "25360",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020632s031ltr.pdf",
              "date": "20081230",
              "type": "Letter"
            },
            {
              "id": "34995",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020632s031lbl.pdf",
              "date": "20090102",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20021008",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "20779",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020632_S015_MERIDIA.pdf",
              "date": "20080219",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20051208",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "44062",
              "url": "http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm191652.htm",
              "date": "20070709",
              "type": "Other Important Information from FDA"
            },
            {
              "id": "52193",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020632s021_sibutramine_Meridia-MedRev.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "52194",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020632s021_sibutramine_Meridia-ClinPharmRev.pdf",
              "date": "19000101",
              "type": "Pediatric Clinical Pharmacology Review"
            },
            {
              "id": "52195",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20632s021_SIBUTRAMINE HCL MONOHYDRATE_Clinical_Pharm_BPCA.pdf",
              "date": "19000101",
              "type": "Pediatric Clinical Pharmacology Review"
            },
            {
              "id": "52196",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020632s021_sibutramine_Meridia-StatsRev.pdf",
              "date": "19000101",
              "type": "Pediatric Statistical Review"
            },
            {
              "id": "52197",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020632s021_sibutramine_Meridia-StatsRev_amend.pdf",
              "date": "19000101",
              "type": "Pediatric Statistical Review"
            },
            {
              "id": "52198",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020632_sibutramine_Merdia_WR_orig.pdf",
              "date": "19000101",
              "type": "Pediatric Written Request"
            },
            {
              "id": "63741",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N20-632S21-Sibutramine-Statistical-BPCA---not-amend.pdf",
              "date": "20200626",
              "type": "Pediatric Statistical Review"
            },
            {
              "id": "2918",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020632s021ltr.pdf",
              "date": "20051215",
              "type": "Letter"
            },
            {
              "id": "34992",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020632s021lbl.pdf",
              "date": "20051215",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20020425",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20010216",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "25358",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20632S008011ltr.pdf",
              "date": "20010216",
              "type": "Letter"
            },
            {
              "id": "34991",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20632s8s11LBL.pdf",
              "date": "20010216",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "34",
          "submission_status": "AP",
          "submission_status_date": "20100804",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "43656",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035MedGuide.pdf",
              "date": "20100810",
              "type": "Medication Guide"
            },
            {
              "id": "25362",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020632s034,s035ltr.pdf",
              "date": "20100810",
              "type": "Letter"
            },
            {
              "id": "34996",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035lbl.pdf",
              "date": "20100810",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20060823",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "2920",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020632s026ltr.pdf",
              "date": "20060918",
              "type": "Letter"
            },
            {
              "id": "34994",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020632s026lbl.pdf",
              "date": "20060829",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19980807",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "32",
          "submission_status": "AP",
          "submission_status_date": "20090504",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12875",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020632s032lbl.pdf",
              "date": "20090511",
              "type": "Label"
            },
            {
              "id": "25361",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020632s032ltr.pdf",
              "date": "20090506",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20050729",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "34993",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020632s024lbl.pdf",
              "date": "20050803",
              "type": "Label"
            },
            {
              "id": "2919",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020632s024ltr.pdf",
              "date": "20050803",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "30",
          "submission_status": "AP",
          "submission_status_date": "20080529",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "2921",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020632s030, 020381s032ltr.pdf",
              "date": "20080530",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA020632",
      "sponsor_name": "ABBOTT",
      "products": [
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "MERIDIA",
          "active_ingredients": [
            {
              "name": "SIBUTRAMINE HYDROCHLORIDE",
              "strength": "10MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "003",
          "reference_drug": "No",
          "brand_name": "MERIDIA",
          "active_ingredients": [
            {
              "name": "SIBUTRAMINE HYDROCHLORIDE",
              "strength": "15MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "MERIDIA",
          "active_ingredients": [
            {
              "name": "SIBUTRAMINE HYDROCHLORIDE",
              "strength": "5MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}