Gabapentin

Manages postherpetic neuralgia. ANDA 78787, held by Aurobindo Pharma. Gabapentin.

As of Nov 14, 2026, ANDA 78787 (Gabapentin), held by Aurobindo Pharma, was first approved by FDA on Jan 31, 2008, with 16 approved supplements and 0 published complete response letters.

First approved: Jan 31, 2008
Supplements approved: 16
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 17 submissions below

Date	Submission	Status	Documents
Jan 31, 2008	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 17 submissions, including labeling and manufacturing supplements


Oct 15, 2024	Supplement 41Labeling · Standard review	Approved	None posted
Aug 2, 2023	Supplement 32Labeling · Standard review	Approved	None posted
Aug 2, 2023	Supplement 34Labeling · Standard review	Approved	None posted
Apr 23, 2018	Supplement 16Labeling · Standard review	Approved	None posted
Apr 23, 2018	Supplement 17Labeling · Standard review	Approved	None posted
Apr 23, 2018	Supplement 20Labeling · Standard review	Approved	None posted
Apr 23, 2018	Supplement 22Labeling · Standard review	Approved	None posted
Apr 23, 2018	Supplement 25Manufacturing	Approved	None posted
Mar 5, 2015	Supplement 8Manufacturing	Approved	None posted
Nov 8, 2014	Supplement 10Labeling · Standard review	Approved	None posted
Nov 8, 2014	Supplement 14Labeling · Standard review	Approved	None posted
Jun 17, 2014	Supplement 3Manufacturing	Approved	None posted
Dec 15, 2011	Supplement 7Labeling	Approved	None posted
Aug 30, 2011	Supplement 6Labeling	Approved	None posted
Jan 10, 2011	Supplement 4Labeling	Approved	None posted
Nov 18, 2009	Supplement 1Labeling	Approved	None posted
Jan 31, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78787
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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