Gabapentin

Manages postherpetic neuralgia. ANDA 90858, held by Alkem. Gabapentin.

As of Nov 14, 2026, ANDA 90858 (Gabapentin), held by Alkem, was first approved by FDA on Dec 17, 2010, with 12 approved supplements and 0 published complete response letters.

First approved: Dec 17, 2010
Supplements approved: 12
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 13 submissions below

Date	Submission	Status	Documents
Dec 17, 2010	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 13 submissions, including labeling and manufacturing supplements


Feb 12, 2026	Supplement 42Labeling · Standard review	Approved	None posted
Dec 19, 2024	Supplement 41Labeling · Standard review	Approved	None posted
Apr 18, 2023	Supplement 35Labeling · Standard review	Approved	None posted
Apr 18, 2023	Supplement 33Labeling · Standard review	Approved	None posted
Apr 18, 2023	Supplement 31Labeling · Standard review	Approved	None posted
Mar 25, 2020	Supplement 17Labeling · Standard review	Approved	None posted
Mar 25, 2020	Supplement 13Labeling · Standard review	Approved	None posted
Dec 29, 2016	Supplement 11Labeling · Standard review	Approved	None posted
Dec 29, 2016	Supplement 9Labeling · Standard review	Approved	None posted
Nov 8, 2014	Supplement 4Labeling · Standard review	Approved	None posted
May 20, 2012	Supplement 3Manufacturing	Approved	None posted
Jul 14, 2011	Supplement 1Labeling	Approved	None posted
Dec 17, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 90858
Drugs@FDA: Overview at FDA
Company: Alkem Laboratories

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