Gabapentin

Manages postherpetic neuralgia. ANDA 75350, held by Actavis Elizabeth. Gabapentin.

As of Nov 14, 2026, ANDA 75350 (Gabapentin), held by Actavis Elizabeth, was first approved by FDA on Sep 12, 2003, with 17 approved supplements and 0 published complete response letters.

First approved: Sep 12, 2003
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Gabapentin capsules are 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 Gabapentin capsules are 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 18 submissions below

Date	Submission	Status	Documents
Sep 12, 2003	Original application	Approved	Review

Products

3 strengths and forms


Gabapentin100MG · capsule;oral	Gabapentin	Rx
Gabapentin300MG · capsule;oral	Gabapentin	Rx
Gabapentin400MG · capsule;oral	Gabapentin	Rx

All 18 submissions, including labeling and manufacturing supplements


Jan 29, 2026	Supplement 80Labeling · Standard review	Approved	None posted
Jan 7, 2025	Supplement 77Labeling · Standard review	Approved	None posted
Jan 7, 2025	Supplement 72Labeling · Standard review	Approved	None posted
Apr 26, 2021	Supplement 67Labeling · Standard review	Approved	None posted
Jul 21, 2020	Supplement 66Labeling · Standard review	Approved	None posted
Jul 21, 2020	Supplement 60Labeling · Standard review	Approved	None posted
Jan 13, 2016	Supplement 57Labeling · Standard review	Approved	None posted
Jan 13, 2016	Supplement 49Labeling · Standard review	Approved	None posted
Mar 16, 2015	Supplement 54Labeling · Standard review	Approved	None posted
Aug 28, 2012	Supplement 32Manufacturing	Approved	None posted
Apr 11, 2012	Supplement 35Labeling	Approved	None posted
Jun 24, 2011	Supplement 29Labeling	Approved	None posted
Jun 24, 2011	Supplement 28Labeling	Approved	None posted
May 13, 2010	Supplement 22Labeling	Approved	None posted
Dec 5, 2006	Supplement 14Labeling	Approved	None posted
Dec 23, 2005	Supplement 9Labeling	Approved	None posted
Apr 8, 2005	Supplement 4Labeling	Approved	None posted
Sep 12, 2003	Original application	Approved	Review

Identifiers

Application: ANDA 75350
Drugs@FDA: Overview at FDA
Company: Actavis Elizabeth

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