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FDA NDA · NDA020882

NEURONTIN

gabapentin

Sponsor: VIATRIS

APPLICATION
NDA020882
TYPE
NDA
ORIGINAL APPROVAL
1998-10-09
LATEST ACTION
2025-04-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NEURONTIN · ReferencePrescription
GABAPENTIN 600MG · TABLET · ORAL
NEURONTIN · ReferencePrescription
GABAPENTIN 800MG · TABLET · ORAL

Approval history

2025-04-25Labeling · Supplement 60 · standard — Label ↗AP
2024-07-12Labeling · Supplement 57 · standard — Letter ↗AP
2020-12-16Labeling · Supplement 50 · standard — Letter ↗AP
2020-04-02Labeling · Supplement 49 · 901 required — Letter ↗AP
2017-10-18Labeling · Supplement 47 · standard — Letter ↗AP
2017-03-24Labeling · Supplement 45 · standard — Label ↗AP
2015-09-14Labeling · Supplement 43 · standard — Letter ↗AP
2015-04-21Labeling · Supplement 44 · standard — Letter ↗AP
2014-08-18Labeling · Supplement 41 · standard — Letter ↗AP
2013-05-01Labeling · Supplement 38 · standard — Label ↗AP
2013-05-01Labeling · Supplement 40 · standard — Label ↗AP
2013-05-01Labeling · Supplement 39 · standard — Label ↗AP
2011-08-10Labeling · Supplement 35 · unknown — Label ↗AP
2011-03-01Labeling · Supplement 22 · standard — Letter ↗AP
2010-10-11Labeling · Supplement 30 · standard — Label ↗AP
2009-04-23Labeling · Supplement 28 · 901 required — Letter ↗AP
2006-05-03Labeling · Supplement 21 · standard — Letter ↗AP
2005-02-18Labeling · Supplement 15 · standard — Letter ↗AP
2004-04-30Manufacturing (CMC) · Supplement 17 · standard — Letter ↗AP
2002-12-19Manufacturing (CMC) · Supplement 12 · standardAP
2002-10-24Manufacturing (CMC) · Supplement 10 · standardAP
2002-08-15Efficacy · Supplement 9 · standard — Letter ↗AP
2002-01-30Labeling · Supplement 8 · standard — Letter ↗AP
2002-01-18Manufacturing (CMC) · Supplement 7 · standardAP
2000-10-12Efficacy · Supplement 2 · standard — Review ↗AP
2000-09-19Manufacturing (CMC) · Supplement 5 · standardAP
1998-10-09Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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