Gabapentin

Manages postherpetic neuralgia. ANDA 77242, held by Sun Pharm Inds Ltd. Gabapentin.

As of Nov 14, 2026, ANDA 77242 (Gabapentin), held by Sun Pharm Inds Ltd, was first approved by FDA on Aug 24, 2006, with 13 approved supplements and 0 published complete response letters.

First approved: Aug 24, 2006
Supplements approved: 13
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 14 submissions below

Date	Submission	Status	Documents
Aug 24, 2006	Original application	Approved	None posted

Products

3 strengths and forms


Gabapentin100MG · capsule;oral	Gabapentin	Discontinued
Gabapentin300MG · capsule;oral	Gabapentin	Discontinued
Gabapentin400MG · capsule;oral	Gabapentin	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Dec 2, 2024	Supplement 31Labeling · Standard review	Approved	None posted
Dec 2, 2024	Supplement 30Labeling · Standard review	Approved	None posted
Dec 2, 2024	Supplement 28Labeling · Standard review	Approved	None posted
Oct 27, 2020	Supplement 27Labeling · Standard review	Approved	None posted
Aug 7, 2020	Supplement 21Labeling · Standard review	Approved	None posted
Aug 7, 2020	Supplement 20Labeling · Standard review	Approved	None posted
Aug 7, 2020	Supplement 19Labeling · Standard review	Approved	None posted
Sep 10, 2015	Supplement 18Labeling · Standard review	Approved	None posted
Dec 12, 2014	Supplement 16Labeling · Standard review	Approved	None posted
Dec 12, 2014	Supplement 12Labeling · Standard review	Approved	None posted
Mar 30, 2011	Supplement 10REMS	Approved	None posted
Mar 30, 2011	Supplement 9Labeling	Approved	None posted
May 13, 2010	Supplement 7Labeling	Approved	None posted
Aug 24, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 77242
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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