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FDA NDA · NDA021129

NEURONTIN

gabapentin

Sponsor: VIATRIS

APPLICATION
NDA021129
TYPE
NDA
ORIGINAL APPROVAL
2000-03-02
LATEST ACTION
2025-04-25
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

NEURONTIN · ReferencePrescription
GABAPENTIN 250MG/5ML · SOLUTION · ORAL

Approval history

2025-04-25Labeling · Supplement 59 · standard — Label ↗AP
2024-07-12Labeling · Supplement 56 · standard — Letter ↗AP
2020-12-16Labeling · Supplement 50 · standard — Letter ↗AP
2020-04-02Labeling · Supplement 49 · 901 required — Letter ↗AP
2017-10-18Labeling · Supplement 46 · standard — Letter ↗AP
2017-03-24Labeling · Supplement 44 · standard — Label ↗AP
2015-09-14Labeling · Supplement 42 · standard — Letter ↗AP
2015-04-21Labeling · Supplement 43 · standard — Label ↗AP
2014-08-18Labeling · Supplement 39 · standard — Letter ↗AP
2014-04-15Manufacturing (CMC) · Supplement 41 · standardAP
2013-07-18Manufacturing (CMC) · Supplement 38 · standardAP
2013-05-01Labeling · Supplement 36 · unknown — Letter ↗AP
2013-05-01Labeling · Supplement 37 · standard — Letter ↗AP
2013-05-01Labeling · Supplement 35 · standard — Letter ↗AP
2011-08-10Labeling · Supplement 33 · unknown — Letter ↗AP
2011-03-01Labeling · Supplement 22 · standard — Letter ↗AP
2010-10-11Labeling · Supplement 29 · standard — Label ↗AP
2009-04-23Labeling · Supplement 27 · 901 required — Label ↗AP
2006-05-03Labeling · Supplement 20 · standard — Letter ↗AP
2005-02-18Labeling · Supplement 16 · standard — Label ↗AP
2002-12-19Manufacturing (CMC) · Supplement 13 · standardAP
2002-10-24Manufacturing (CMC) · Supplement 11 · standardAP
2002-08-15Efficacy · Supplement 10 · standard — Letter ↗AP
2002-01-30Labeling · Supplement 9 · standard — Letter ↗AP
2002-01-18Manufacturing (CMC) · Supplement 8 · standardAP
2001-04-26Manufacturing (CMC) · Supplement 6 · standardAP
2000-10-12Efficacy · Supplement 5 · standard — Review ↗AP
2000-09-19Manufacturing (CMC) · Supplement 4 · standardAP
2000-03-02Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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