Neurontin

Manages postherpetic neuralgia. NDA 20235, held by Viatris. Gabapentin.

As of Nov 13, 2026, NDA 20235 (Neurontin), held by Viatris, was first approved by FDA on Dec 30, 1993, with 37 approved supplements and 0 published complete response letters.

First approved: Dec 30, 1993
Review: Priority
Supplements approved: 37
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

NEURONTIN is indicated for:

Management of postherpetic neuralgia in adults
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy NEURONTIN is indicated for:
Postherpetic neuralgia in adults
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 38 submissions below


Aug 15, 2002	Supplement 23Efficacy (new indication or use) · Standard review	Approved	Letter
Oct 12, 2000	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Sep 29, 1998	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Dec 30, 1993	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

3 strengths and forms


Neurontin100MG · capsule;oral	Gabapentin	RxReference drug
Neurontin300MG · capsule;oral	Gabapentin	RxReference drug
Neurontin400MG · capsule;oral	Gabapentin	RxReference drug

All 38 submissions, including labeling and manufacturing supplements


Apr 25, 2025	Supplement 79Labeling · Standard review	Approved	Letter Medication Guide Label
Jul 12, 2024	Supplement 76Labeling · Standard review	Approved	Label Letter
Dec 16, 2020	Supplement 69Labeling · Standard review	Approved	Letter Label
Apr 2, 2020	Supplement 68Labeling	Approved	Label Letter
Oct 18, 2017	Supplement 64Labeling · Standard review	Approved	Label Letter
Mar 24, 2017	Supplement 62Labeling · Standard review	Approved	Letter Label
Sep 14, 2015	Supplement 60Labeling · Standard review	Approved	Label Letter
Apr 21, 2015	Supplement 61Labeling · Standard review	Approved	Letter Label
Aug 18, 2014	Supplement 57Labeling · Standard review	Approved	Letter Label
May 1, 2013	Supplement 56Labeling · Standard review	Approved	Label Letter
May 1, 2013	Supplement 55Labeling · Standard review	Approved	Label Letter
May 1, 2013	Supplement 54Labeling · Standard review	Approved	Label Letter
Aug 10, 2011	Supplement 50Labeling	Approved	Letter Label
Mar 1, 2011	Supplement 36Labeling · Standard review	Approved	Letter Label
Oct 11, 2010	Supplement 43Labeling · Standard review	Approved	Letter Label
Nov 20, 2009	Supplement 44Manufacturing	Approved	None posted
Apr 23, 2009	Supplement 41Labeling	Approved	Letter Label
May 3, 2006	Supplement 35Labeling · Standard review	Approved	Letter
Feb 18, 2005	Supplement 29Labeling · Standard review	Approved	Letter Label
Dec 19, 2002	Supplement 26Manufacturing · Priority review	Approved	None posted
Oct 24, 2002	Supplement 24Manufacturing · Priority review	Approved	None posted
Aug 15, 2002	Supplement 23Efficacy (new indication or use) · Standard review	Approved	Letter
Jan 30, 2002	Supplement 22Labeling · Standard review	Approved	Letter
Jan 18, 2002	Supplement 21Manufacturing · Priority review	Approved	None posted
Feb 8, 2001	Supplement 20Manufacturing · Priority review	Approved	None posted
Feb 8, 2001	Supplement 19Manufacturing · Priority review	Approved	None posted
Jan 18, 2001	Supplement 18Manufacturing · Priority review	Approved	None posted
Oct 12, 2000	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Aug 16, 2000	Supplement 17Manufacturing · Priority review	Approved	None posted
Jul 21, 2000	Supplement 16Manufacturing · Priority review	Approved	None posted
May 15, 2000	Supplement 14Manufacturing · Priority review	Approved	None posted
Sep 29, 1998	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Feb 12, 1998	Supplement 9Manufacturing · Priority review	Approved	None posted
Dec 9, 1996	Supplement 5Manufacturing · Priority review	Approved	None posted
May 28, 1996	Supplement 4Manufacturing · Priority review	Approved	None posted
Apr 9, 1996	Supplement 3Manufacturing · Priority review	Approved	None posted
Nov 14, 1994	Supplement 1Labeling · Standard review	Approved	None posted
Dec 30, 1993	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 20235
Drugs@FDA: Overview at FDA
Company: Viatris

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters