Gabapentin

Manages postherpetic neuralgia. ANDA 200651, held by Aurobindo Pharma Ltd. Gabapentin.

As of Nov 14, 2026, ANDA 200651 (Gabapentin), held by Aurobindo Pharma Ltd, was first approved by FDA on Oct 6, 2011, with 11 approved supplements and 0 published complete response letters.

First approved: Oct 6, 2011
Supplements approved: 11
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 12 submissions below

Date	Submission	Status	Documents
Oct 6, 2011	Original application	Approved	None posted

Products

2 strengths and forms


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

All 12 submissions, including labeling and manufacturing supplements


Oct 30, 2026	Supplement 35Labeling · Standard review	Approved	None posted
Sep 26, 2024	Supplement 32Labeling · Standard review	Approved	None posted
Oct 15, 2021	Supplement 22Labeling · Standard review	Approved	None posted
Oct 19, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Oct 19, 2020	Supplement 9Labeling · Standard review	Approved	None posted
Oct 19, 2020	Supplement 11Labeling · Standard review	Approved	None posted
Oct 19, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Oct 19, 2020	Supplement 20Labeling · Standard review	Approved	None posted
Mar 31, 2015	Supplement 5Manufacturing	Approved	None posted
Feb 18, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Oct 23, 2014	Supplement 3Labeling · Standard review	Approved	None posted
Oct 6, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 200651
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