Gabapentin

Manages postherpetic neuralgia. ANDA 77662, held by Glenmark Pharms Ltd. Gabapentin.

As of Nov 14, 2026, ANDA 77662 (Gabapentin), held by Glenmark Pharms Ltd, was first approved by FDA on Aug 18, 2006, with 14 approved supplements and 0 published complete response letters.

First approved: Aug 18, 2006
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Gabapentin tablets 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 tablets 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 15 submissions below

Date	Submission	Status	Documents
Aug 18, 2006	Original application	Approved	None posted

Products

2 strengths and forms


Gabapentin600MG · tablet;oral	Gabapentin	Rx
Gabapentin800MG · tablet;oral	Gabapentin	Rx

All 15 submissions, including labeling and manufacturing supplements


Oct 2, 2024	Supplement 36Labeling · Standard review	Approved	None posted
Aug 2, 2023	Supplement 29Labeling · Standard review	Approved	None posted
Oct 27, 2020	Supplement 26Labeling · Standard review	Approved	None posted
Oct 27, 2020	Supplement 23Labeling · Standard review	Approved	None posted
Oct 5, 2017	Supplement 21Labeling · Standard review	Approved	None posted
Nov 8, 2016	Supplement 19Labeling · Standard review	Approved	None posted
Nov 8, 2016	Supplement 17Labeling · Standard review	Approved	None posted
Nov 8, 2016	Supplement 15Labeling · Standard review	Approved	None posted
Mar 25, 2014	Supplement 13Labeling · Standard review	Approved	None posted
Nov 25, 2011	Supplement 10Labeling	Approved	None posted
Sep 29, 2011	Supplement 9Labeling	Approved	None posted
Aug 29, 2011	Supplement 8Labeling	Approved	None posted
Nov 20, 2009	Supplement 6Labeling	Approved	None posted
Oct 19, 2006	Supplement 1Labeling	Approved	None posted
Aug 18, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 77662
Drugs@FDA: Overview at FDA
Company: Glenmark Pharmaceuticals

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