← FDA DRUG APPROVALS

FDA NDA · NDA020235

NEURONTIN

gabapentin

Sponsor: VIATRIS

APPLICATION
NDA020235
TYPE
NDA
ORIGINAL APPROVAL
1993-12-30
LATEST ACTION
2025-04-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

NEURONTIN · ReferencePrescription
GABAPENTIN 300MG · CAPSULE · ORAL
NEURONTIN · ReferencePrescription
GABAPENTIN 400MG · CAPSULE · ORAL
NEURONTIN · ReferencePrescription
GABAPENTIN 100MG · CAPSULE · ORAL

Approval history

2025-04-25Labeling · Supplement 79 · standard — Label ↗AP
2024-07-12Labeling · Supplement 76 · standard — Letter ↗AP
2020-12-16Labeling · Supplement 69 · standard — Letter ↗AP
2020-04-02Labeling · Supplement 68 · 901 required — Letter ↗AP
2017-10-18Labeling · Supplement 64 · standard — Letter ↗AP
2017-03-24Labeling · Supplement 62 · standard — Label ↗AP
2015-09-14Labeling · Supplement 60 · standard — Label ↗AP
2015-04-21Labeling · Supplement 61 · standard — Letter ↗AP
2014-08-18Labeling · Supplement 57 · standard — Letter ↗AP
2013-05-01Labeling · Supplement 55 · standard — Letter ↗AP
2013-05-01Labeling · Supplement 56 · standard — Label ↗AP
2013-05-01Labeling · Supplement 54 · standard — Letter ↗AP
2011-08-10Labeling · Supplement 50 · unknown — Letter ↗AP
2011-03-01Labeling · Supplement 36 · standard — Label ↗AP
2010-10-11Labeling · Supplement 43 · standard — Label ↗AP
2009-11-20Manufacturing (CMC) · Supplement 44AP
2009-04-23Labeling · Supplement 41 · 901 required — Letter ↗AP
2006-05-03Labeling · Supplement 35 · standard — Letter ↗AP
2005-02-18Labeling · Supplement 29 · standard — Label ↗AP
2002-12-19Manufacturing (CMC) · Supplement 26 · priorityAP
2002-10-24Manufacturing (CMC) · Supplement 24 · priorityAP
2002-08-15Efficacy · Supplement 23 · standard — Letter ↗AP
2002-01-30Labeling · Supplement 22 · standard — Letter ↗AP
2002-01-18Manufacturing (CMC) · Supplement 21 · priorityAP
2001-02-08Manufacturing (CMC) · Supplement 20 · priorityAP
2001-02-08Manufacturing (CMC) · Supplement 19 · priorityAP
2001-01-18Manufacturing (CMC) · Supplement 18 · priorityAP
2000-10-12Efficacy · Supplement 15 · standard — Review ↗AP
2000-08-16Manufacturing (CMC) · Supplement 17 · priorityAP
2000-07-21Manufacturing (CMC) · Supplement 16 · priorityAP
2000-05-15Manufacturing (CMC) · Supplement 14 · priorityAP
1998-09-29Efficacy · Supplement 11 · standard — Review ↗AP
1998-02-12Manufacturing (CMC) · Supplement 9 · priorityAP
1996-12-09Manufacturing (CMC) · Supplement 5 · priorityAP
1996-05-28Manufacturing (CMC) · Supplement 4 · priorityAP
1996-04-09Manufacturing (CMC) · Supplement 3 · priorityAP
1994-11-14Labeling · Supplement 1 · standardAP
1993-12-30Type 1 - New Molecular Entity · Original · priorityAP
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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