{
  "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": "2026-05-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20010925",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "14613",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21192s2lbl.pdf",
              "date": "20030501",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20121031",
          "review_priority": "901 REQUIRED",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "36322",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020261s048,021192s021lbl.pdf",
              "date": "20121106",
              "type": "Label"
            },
            {
              "id": "4608",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020261Orig1s048,021192s021ltr.pdf",
              "date": "20121105",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20070612",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "36319",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020261s039,021192s013lbl.pdf",
              "date": "20070614",
              "type": "Label"
            },
            {
              "id": "27031",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020261s039, 021192s013ltr.pdf",
              "date": "20070614",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20060410",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "4605",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020261s035, s036, 021192s010, s011ltr.pdf",
              "date": "20060413",
              "type": "Letter"
            },
            {
              "id": "14617",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021192,s010,011,020261s035,s036lbl.pdf",
              "date": "20060412",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20170804",
          "review_priority": "901 REQUIRED",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "49273",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020261s052,021192s026lbl.pdf",
              "date": "20170808",
              "type": "Label"
            },
            {
              "id": "49282",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020261Orig1s052,021192Orig1s026ltr.pdf",
              "date": "20170808",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20030527",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "14614",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20261se1-033,21192se1-005_lescol_lbl.pdf",
              "date": "20030608",
              "type": "Label"
            },
            {
              "id": "27028",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20261se1-033,21192se1-005ltr.pdf",
              "date": "20030608",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20110617",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "27032",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020261s042,021192s016ltr.pdf",
              "date": "20110628",
              "type": "Letter"
            },
            {
              "id": "36320",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020261s042,021192s016lbl.pdf",
              "date": "20110628",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20020211",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "42014",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021192_s003_LESCOL_CAPSULES.pdf",
              "date": "20080801",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20010924",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20130625",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20060322",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "36318",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020261S037,021192S012lbl.pdf",
              "date": "20060405",
              "type": "Label"
            },
            {
              "id": "4606",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020261S037,021192S012ltr.pdf",
              "date": "20060405",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20060410",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "14616",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021192,s010,011,020261s035,s036lbl.pdf",
              "date": "20060412",
              "type": "Label"
            },
            {
              "id": "27030",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020261s035, s036, 021192s010, s011ltr.pdf",
              "date": "20060413",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20001006",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "42013",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-192_Lescol.html",
              "date": "20040324",
              "type": "Review"
            },
            {
              "id": "14612",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-192_Lescol_Prntlbl.pdf",
              "date": "20040608",
              "type": "Label"
            },
            {
              "id": "27027",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21192ltr.pdf",
              "date": "20001006",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "29",
          "submission_status": "AP",
          "submission_status_date": "20231128",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "76674",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021192s029lbl.pdf",
              "date": "20231129",
              "type": "Label"
            },
            {
              "id": "76680",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021192Orig1s029ltr.pdf",
              "date": "20231129",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20050105",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "14615",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20261s034,21192s008lbl.pdf",
              "date": "20050111",
              "type": "Label"
            },
            {
              "id": "27029",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20261s034,21192s008ltr.pdf",
              "date": "20050111",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20120228",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "44472",
              "title": "Tracked Changes Label",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021192s019-trackedchangeslbl.pdf",
              "date": "20120228",
              "type": "Other"
            },
            {
              "id": "4607",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020261s046,021192s019ltr.pdf",
              "date": "20120228",
              "type": "Letter"
            },
            {
              "id": "21502",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021192s019.pdf",
              "date": "20120330",
              "type": "Review"
            },
            {
              "id": "36321",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021192s019lbl.pdf",
              "date": "20120228",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "31",
          "submission_status": "AP",
          "submission_status_date": "20200925",
          "review_priority": "901 REQUIRED",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "64700",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021192Orig1s031ltr.pdf",
              "date": "20200928",
              "type": "Letter"
            },
            {
              "id": "64727",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021192s031lbl.pdf",
              "date": "20200929",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20020906",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "36317",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20261s32,21192s4lbl.pdf",
              "date": "20020906",
              "type": "Label"
            },
            {
              "id": "4604",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20261slr032,21192slr004ltr.pdf",
              "date": "20020906",
              "type": "Letter"
            },
            {
              "id": "21501",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021192_s004_LESCOL_CAPSULES.pdf",
              "date": "20080801",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20151105",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "NDA021192",
      "sponsor_name": "SANDOZ",
      "openfda": {
        "application_number": [
          "NDA021192"
        ],
        "brand_name": [
          "LESCOL XL",
          "FLUVASTATIN SODIUM ER"
        ],
        "generic_name": [
          "FLUVASTATIN SODIUM"
        ],
        "manufacturer_name": [
          "Sandoz Inc"
        ],
        "product_ndc": [
          "66758-211",
          "0781-8017"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FLUVASTATIN SODIUM"
        ],
        "rxcui": [
          "360507",
          "687048"
        ],
        "spl_id": [
          "726ea2db-f1b0-4b73-a515-02157db88a42",
          "37375ca6-3a81-4d10-9b39-9aee948e51a4"
        ],
        "spl_set_id": [
          "726ea2db-f1b0-4b73-a515-02157db88a42",
          "5ab4296c-87c2-4c64-b218-d620eef51310"
        ],
        "package_ndc": [
          "66758-211-01",
          "66758-211-31",
          "0781-8017-31",
          "0781-8017-01"
        ],
        "unii": [
          "PYF7O1FV7F"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "LESCOL XL",
          "active_ingredients": [
            {
              "name": "FLUVASTATIN SODIUM",
              "strength": "EQ 80MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}