Gabapentin

Manages postherpetic neuralgia. ANDA 78428, held by Amneal Pharms Ny. Gabapentin.

As of Nov 14, 2026, ANDA 78428 (Gabapentin), held by Amneal Pharms Ny, was first approved by FDA on Jul 25, 2007, with 20 approved supplements and 0 published complete response letters.

First approved: Jul 25, 2007
Supplements approved: 20
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 21 submissions below

Date	Submission	Status	Documents
Jul 25, 2007	Original application	Approved	None posted

Products

3 strengths and forms


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

All 21 submissions, including labeling and manufacturing supplements


Dec 10, 2024	Supplement 59Labeling · Standard review	Approved	None posted
Aug 2, 2023	Supplement 53Labeling · Standard review	Approved	None posted
Aug 2, 2023	Supplement 47Labeling · Standard review	Approved	None posted
Aug 21, 2020	Supplement 43Labeling · Standard review	Approved	None posted
Aug 21, 2020	Supplement 36Labeling · Standard review	Approved	None posted
Aug 21, 2020	Supplement 33Labeling · Standard review	Approved	None posted
Nov 8, 2016	Supplement 31Labeling · Standard review	Approved	None posted
Nov 8, 2016	Supplement 29Labeling · Standard review	Approved	None posted
Nov 8, 2016	Supplement 28Labeling · Standard review	Approved	None posted
Nov 8, 2016	Supplement 27Labeling · Standard review	Approved	None posted
Nov 8, 2016	Supplement 26Labeling · Standard review	Approved	None posted
Nov 8, 2016	Supplement 25Labeling · Standard review	Approved	None posted
Nov 8, 2016	Supplement 24Labeling · Standard review	Approved	None posted
Apr 23, 2014	Supplement 22Labeling · Standard review	Approved	None posted
Apr 19, 2012	Supplement 17Labeling	Approved	None posted
Apr 17, 2012	Supplement 9Manufacturing	Approved	None posted
Dec 16, 2011	Supplement 14Manufacturing	Approved	None posted
Mar 30, 2011	Supplement 15Labeling	Approved	None posted
May 17, 2010	Supplement 7Labeling	Approved	None posted
May 17, 2010	Supplement 4Labeling	Approved	None posted
Jul 25, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78428
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals of New York

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