Gabapentin

Treats partial onset seizures, with and without secondary generalization. ANDA 78926, held by Zydus Pharms USA Inc. Gabapentin.

As of Nov 14, 2026, ANDA 78926 (Gabapentin), held by Zydus Pharms USA Inc, was first approved by FDA on Feb 11, 2011, with 12 approved supplements and 0 published complete response letters.

First approved: Feb 11, 2011
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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 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

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Feb 11, 2011	Original application	Approved	None posted

Products

2 strengths and forms


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

All 13 submissions, including labeling and manufacturing supplements


Sep 19, 2025	Supplement 20Labeling · Standard review	Approved	None posted
Oct 3, 2024	Supplement 19Labeling · Standard review	Approved	None posted
Sep 9, 2021	Supplement 18Labeling · Standard review	Approved	None posted
Oct 28, 2020	Supplement 9Labeling · Standard review	Approved	None posted
Oct 28, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Oct 28, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Oct 28, 2020	Supplement 15Labeling · Standard review	Approved	None posted
Oct 28, 2020	Supplement 17Labeling · Standard review	Approved	None posted
Nov 8, 2014	Supplement 5Labeling · Standard review	Approved	None posted
Nov 8, 2014	Supplement 7Labeling · Standard review	Approved	None posted
Apr 11, 2012	Supplement 2Labeling	Approved	None posted
Aug 30, 2011	Supplement 1Labeling	Approved	None posted
Feb 11, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 78926
Drugs@FDA: Overview at FDA
Company: Zydus Pharmaceuticals (USA)

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