Neurontin

Manages postherpetic neuralgia. NDA 21129, held by Viatris. Gabapentin.

As of Nov 13, 2026, NDA 21129 (Neurontin), held by Viatris, was first approved by FDA on Mar 2, 2000, with 28 approved supplements and 0 published complete response letters.

First approved: Mar 2, 2000
Review: Standard
Supplements approved: 28
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 29 submissions below

Date	Submission	Status	Documents
Aug 15, 2002	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter
Oct 12, 2000	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Review
Mar 2, 2000	Original applicationNew dosage form · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Neurontin250MG/5ML · solution;oral	Gabapentin	RxReference drug

All 29 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 25, 2025	Supplement 59Labeling · Standard review	Approved	Letter Label Medication Guide
Jul 12, 2024	Supplement 56Labeling · Standard review	Approved	Label Letter
Dec 16, 2020	Supplement 50Labeling · Standard review	Approved	Letter Label
Apr 2, 2020	Supplement 49Labeling	Approved	Label Letter
Oct 18, 2017	Supplement 46Labeling · Standard review	Approved	Label Letter
Mar 24, 2017	Supplement 44Labeling · Standard review	Approved	Letter Label
Sep 14, 2015	Supplement 42Labeling · Standard review	Approved	Label Letter
Apr 21, 2015	Supplement 43Labeling · Standard review	Approved	Label Letter
Aug 18, 2014	Supplement 39Labeling · Standard review	Approved	Letter Label
Apr 15, 2014	Supplement 41Manufacturing · Standard review	Approved	None posted
Jul 18, 2013	Supplement 38Manufacturing · Standard review	Approved	None posted
May 1, 2013	Supplement 37Labeling · Standard review	Approved	Label Letter
May 1, 2013	Supplement 36Labeling	Approved	Label Letter
May 1, 2013	Supplement 35Labeling · Standard review	Approved	Label Letter
Aug 10, 2011	Supplement 33Labeling	Approved	Letter Label
Mar 1, 2011	Supplement 22Labeling · Standard review	Approved	Letter Label
Oct 11, 2010	Supplement 29Labeling · Standard review	Approved	Letter Label
Apr 23, 2009	Supplement 27Labeling	Approved	Letter Label
May 3, 2006	Supplement 20Labeling · Standard review	Approved	Letter
Feb 18, 2005	Supplement 16Labeling · Standard review	Approved	Label Letter
Dec 19, 2002	Supplement 13Manufacturing · Standard review	Approved	None posted
Oct 24, 2002	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 15, 2002	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter
Jan 30, 2002	Supplement 9Labeling · Standard review	Approved	Letter
Jan 18, 2002	Supplement 8Manufacturing · Standard review	Approved	None posted
Apr 26, 2001	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 12, 2000	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Review
Sep 19, 2000	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 2, 2000	Original applicationNew dosage form · Standard review	Approved	Review

Identifiers

Application: NDA 21129
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