Gabapentin

Manages postherpetic neuralgia. ANDA 77661, held by Rubicon Research. Gabapentin.

As of Nov 14, 2026, ANDA 77661 (Gabapentin), held by Rubicon Research, was first approved by FDA on Sep 13, 2006, with 14 approved supplements and 0 published complete response letters.

First approved: Sep 13, 2006
Supplements approved: 14
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 15 submissions below

Date	Submission	Status	Documents
Sep 13, 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


Jun 25, 2026	Supplement 25Labeling · Standard review	Approved	None posted
Sep 21, 2023	Supplement 20Labeling · Standard review	Approved	None posted
Sep 21, 2023	Supplement 22Labeling · Standard review	Approved	None posted
Oct 21, 2020	Supplement 14Labeling · Standard review	Approved	None posted
Oct 21, 2020	Supplement 16Labeling · Standard review	Approved	None posted
Oct 21, 2020	Supplement 18Labeling · Standard review	Approved	None posted
Oct 21, 2020	Supplement 19Labeling · Standard review	Approved	None posted
Sep 17, 2015	Supplement 13Labeling · Standard review	Approved	None posted
Apr 17, 2015	Supplement 8Labeling · Standard review	Approved	None posted
Apr 17, 2015	Supplement 12Labeling · Standard review	Approved	None posted
Apr 9, 2013	Supplement 9REMS	Approved	None posted
Aug 26, 2011	Supplement 7Labeling	Approved	None posted
Jan 31, 2011	Supplement 4Labeling	Approved	None posted
Aug 3, 2010	Supplement 3Labeling	Approved	None posted
Sep 13, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 77661
Drugs@FDA: Overview at FDA
Company: Rubicon Research

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