Gabapentin

Manages postherpetic neuralgia. ANDA 75360, held by Granules. Gabapentin.

As of Nov 14, 2026, ANDA 75360 (Gabapentin), held by Granules, was first approved by FDA on Apr 6, 2005, with 15 approved supplements and 0 published complete response letters.

First approved: Apr 6, 2005
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Gabapentin 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 Gabapentin 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 16 submissions below

Date	Submission	Status	Documents
Apr 6, 2005	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 16 submissions, including labeling and manufacturing supplements


Aug 26, 2025	Supplement 35Labeling · Standard review	Approved	None posted
Dec 19, 2024	Supplement 34Labeling · Standard review	Approved	None posted
Mar 5, 2021	Supplement 28Labeling · Standard review	Approved	None posted
Jul 28, 2020	Supplement 19Labeling · Standard review	Approved	None posted
Jul 28, 2020	Supplement 22Labeling · Standard review	Approved	None posted
Jul 28, 2020	Supplement 23Labeling · Standard review	Approved	None posted
Jul 28, 2020	Supplement 25Labeling · Standard review	Approved	None posted
Sep 17, 2015	Supplement 18Labeling · Standard review	Approved	None posted
Apr 17, 2015	Supplement 11Labeling · Standard review	Approved	None posted
Apr 17, 2015	Supplement 13Labeling · Standard review	Approved	None posted
Apr 17, 2015	Supplement 17Labeling · Standard review	Approved	None posted
Aug 29, 2011	Supplement 10Labeling	Approved	None posted
Aug 3, 2010	Supplement 7Labeling	Approved	None posted
Apr 25, 2007	Supplement 5Labeling	Approved	None posted
Dec 7, 2006	Supplement 3Labeling	Approved	None posted
Apr 6, 2005	Original application	Approved	Review

Identifiers

Application: ANDA 75360
Drugs@FDA: Overview at FDA
Company: Granules India

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