{ "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": "2026-08-21", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "submissions": [ { "submission_type": "SUPPL", "submission_number": "14", "submission_status": "AP", "submission_status_date": "20000515", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "20", "submission_status": "AP", "submission_status_date": "20010208", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "57", "submission_status": "AP", "submission_status_date": "20140818", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "2219", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020235Orig1s057,020882Orig1s041,021129Orig1s039ltr.pdf", "date": "20140820", "type": "Letter" }, { "id": "34407", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020235s057,020882s041,021129s039lbl.pdf", "date": "20140820", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "9", "submission_status": "AP", "submission_status_date": "19980212", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "55", "submission_status": "AP", "submission_status_date": "20130501", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "2218", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020235Orig1s054,s055,s056,020882Orig1s038,s039,s040,021129Orig1s035,s036,s037ltr.pdf", "date": "20130507", "type": "Letter" }, { "id": "34406", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf", "date": "20130509", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "61", "submission_status": "AP", "submission_status_date": "20150421", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "24627", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020235Orig1s061,020882Orig1s044,021129Orig1s043ltr.pdf", "date": "20150511", "type": "Letter" }, { "id": "34408", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020235s061,020882s044,021129s043lbl.pdf", "date": "20150427", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "5", "submission_status": "AP", "submission_status_date": "19961209", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "29", "submission_status": "AP", "submission_status_date": "20050218", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12344", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20235s029,20882s015,21129s016lbl.pdf", "date": "20050223", "type": "Label" }, { "id": "2214", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20235s029,20882s015,21129s016ltr.pdf", "date": "20050223", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "3", "submission_status": "AP", "submission_status_date": "19960409", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "43", "submission_status": "AP", "submission_status_date": "20101011", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12346", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020235s043lbl.pdf", "date": "20101011", "type": "Label" }, { "id": "24624", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020235s043,020882s030,021129s029ltr.pdf", "date": "20101013", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "35", "submission_status": "AP", "submission_status_date": "20060503", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "2215", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020235s035, 020882s021, 021129s020LTR.pdf", "date": "20060505", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "1", "submission_status": "AP", "submission_status_date": "19941114", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "41", "submission_status": "AP", "submission_status_date": "20090423", "review_priority": "901 REQUIRED", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "2216", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020235s041,020882s028ltr.pdf", "date": "20090501", "type": "Letter" }, { "id": "34403", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020235s041,020882s028,021129s027lbl.pdf", "date": "20090428", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "19", "submission_status": "AP", "submission_status_date": "20010208", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "17", "submission_status": "AP", "submission_status_date": "20000816", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "23", "submission_status": "AP", "submission_status_date": "20020815", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "2213", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20235se8-023,20882se8-009,21129se8-010ltr.pdf", "date": "20040610", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "76", "submission_status": "AP", "submission_status_date": "20240712", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "79098", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021129Orig1s056;020235Orig1s076;020882Orig1s057ltr.pdf", "date": "20240715", "type": "Letter" }, { "id": "79102", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021129s056,020882s057,020235s076lbl.pdf", "date": "20240716", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "15", "submission_status": "AP", "submission_status_date": "20001012", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "41221", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-216_20-235S15_20-882S2_21-129S5_Neurontin.html", "date": "20040506", "type": "Review" }, { "id": "12343", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21216lbl.pdf", "date": "20001012", "type": "Label" }, { "id": "24622", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21216ltr.pdf", "date": "20001012", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "68", "submission_status": "AP", "submission_status_date": "20200402", "review_priority": "901 REQUIRED", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "62432", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020235Orig1s068, 020882Orig1s049, 021129Orig1s049ltr.pdf", "date": "20200403", "type": "Letter" }, { "id": "62532", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020235s068,020882s049,021129s049lbl.pdf", "date": "20200410", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "21", "submission_status": "AP", "submission_status_date": "20020118", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "11", "submission_status": "AP", "submission_status_date": "19980929", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "41220", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020235S011.pdf", "date": "19980929", "type": "Review" }, { "id": "24621", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20235s11ltr.pdf", "date": "19980929", "type": "Letter" }, { "id": "34402", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20235s11lbl.pdf", "date": "19980929", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "64", "submission_status": "AP", "submission_status_date": "20171018", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "50105", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/20235Orig1s064,020882Orig1s047,021129Orig1s046ltr.pdf", "date": "20171019", "type": "Letter" }, { "id": "50123", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020235s064_020882s047_021129s046lbl.pdf", "date": "20171020", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "56", "submission_status": "AP", "submission_status_date": "20130501", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12347", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf", "date": "20130509", "type": "Label" }, { "id": "24626", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020235Orig1s054,s055,s056,020882Orig1s038,s039,s040,021129Orig1s035,s036,s037ltr.pdf", "date": "20130507", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "62", "submission_status": "AP", "submission_status_date": "20170324", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "47710", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020235s062,020882s045,021129s044lbl.pdf", "date": "20170327", "type": "Label" }, { "id": "47754", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020235Orig1s062,020882Orig1s045,021129Orig1s044ltr.pdf", "date": "20170329", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "54", "submission_status": "AP", "submission_status_date": "20130501", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "24625", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020235Orig1s054,s055,s056,020882Orig1s038,s039,s040,021129Orig1s035,s036,s037ltr.pdf", "date": "20130507", "type": "Letter" }, { "id": "34405", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf", "date": "20130509", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "60", "submission_status": "AP", "submission_status_date": "20150914", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12348", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020235s060,020882s043,021129s042lbl.pdf", "date": "20150923", "type": "Label" }, { "id": "2220", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020235Orig1s060,020882s043,021129Orig1s042ltr.pdf", "date": "20150917", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "4", "submission_status": "AP", "submission_status_date": "19960528", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "44", "submission_status": "AP", "submission_status_date": "20091120", "review_priority": "N/A", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "36", "submission_status": "AP", "submission_status_date": "20110301", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12345", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020235s036,020882s022,021129s022lbl.pdf", "date": "20110304", "type": "Label" }, { "id": "24623", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020235s036,020882s022,021129s022ltr.pdf", "date": "20110307", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "50", "submission_status": "AP", "submission_status_date": "20110810", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "2217", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020235s050,020882s035,021129s033ltr.pdf", "date": "20110812", "type": "Letter" }, { "id": "34404", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020235s050,020882s035,021129s033lbl.pdf", "date": "20110811", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "26", "submission_status": "AP", "submission_status_date": "20021219", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "79", "submission_status": "AP", "submission_status_date": "20250425", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "82065", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020235s079,020882s060,021129s059lbl.pdf", "date": "20250425", "type": "Label" }, { "id": "82066", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020235s079,020882s060,021129s059lbl.pdf#page=34", "date": "20250429", "type": "Medication Guide" }, { "id": "82118", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020235Orig1s079, 020882Orig1s060, 021129Orig1s059ltr.pdf", "date": "20250501", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "18", "submission_status": "AP", "submission_status_date": "20010118", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "ORIG", "submission_number": "1", "submission_status": "AP", "submission_status_date": "19931230", "review_priority": "PRIORITY", "submission_class_code": "TYPE 1", "submission_class_code_description": "Type 1 - New Molecular Entity" }, { "submission_type": "SUPPL", "submission_number": "24", "submission_status": "AP", "submission_status_date": "20021024", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "16", "submission_status": "AP", "submission_status_date": "20000721", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "69", "submission_status": "AP", "submission_status_date": "20201216", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "65633", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020235Orig1s069, 020882Orig1s050, 021129Orig1s050ltr.pdf", "date": "20201221", "type": "Letter" }, { "id": "65663", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020235s069,020882s050,021129s050lbl.pdf", "date": "20201221", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "22", "submission_status": "AP", "submission_status_date": "20020130", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "2212", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21129s9ltr.pdf", "date": "20020130", "type": "Letter" } ] } ], "application_number": "NDA020235", "sponsor_name": "VIATRIS", "openfda": { "application_number": [ "NDA020235" ], "brand_name": [ "NEURONTIN" ], "generic_name": [ "GABAPENTIN" ], "manufacturer_name": [ "Parke-Davis Div of Pfizer Inc", "Viatris Specialty LLC" ], "product_ndc": [ "0071-0805", "0071-0803", "0071-0806", "0071-0513", "0071-0401", "0071-2012", "58151-281", "58151-282", "58151-283", "58151-284", "58151-285", "58151-290" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "GABAPENTIN" ], "rxcui": [ "105028", "105029", "105030", "261280", "261281", "283523", "310430", "310431", "310432", "310433", "310434", "351973" ], "spl_id": [ "e730d5df-d47b-4d7f-ae3b-bd449f6b1213", "2d43f32d-2d96-4011-84ac-507c3307dc27" ], "spl_set_id": [ "ee9ad9ed-6d9f-4ee1-9d7f-cfad438df388", "97935fd9-1d4a-43b6-a5d9-de994591187b" ], "package_ndc": [ "0071-0803-24", "0071-0803-40", "0071-0805-24", "0071-0805-40", "0071-0806-24", "0071-0806-40", "0071-0513-24", "0071-0401-24", "0071-2012-23", "0071-2012-44", "0071-2012-47", "58151-281-01", "58151-282-01", "58151-283-01", "58151-284-01", "58151-285-01", "58151-290-35" ], "nui": [ "N0000008486" ], "pharm_class_pe": [ "Decreased Central Nervous System Disorganized Electrical Activity [PE]" ], "unii": [ "6CW7F3G59X" ] }, "products": [ { "product_number": "002", "reference_drug": "Yes", "brand_name": "NEURONTIN", "active_ingredients": [ { "name": "GABAPENTIN", "strength": "300MG" } ], "reference_standard": "No", "dosage_form": "CAPSULE", "route": "ORAL", "marketing_status": "Prescription", "te_code": "AB" }, { "product_number": "003", "reference_drug": "Yes", "brand_name": "NEURONTIN", "active_ingredients": [ { "name": "GABAPENTIN", "strength": "400MG" } ], "reference_standard": "Yes", "dosage_form": "CAPSULE", "route": "ORAL", "marketing_status": "Prescription", "te_code": "AB" }, { "product_number": "001", "reference_drug": "Yes", "brand_name": "NEURONTIN", "active_ingredients": [ { "name": "GABAPENTIN", "strength": "100MG" } ], "reference_standard": "No", "dosage_form": "CAPSULE", "route": "ORAL", "marketing_status": "Prescription", "te_code": "AB" } ] } ] }