Gabapentin

Manages postherpetic neuralgia. ANDA 203244, held by Strides Pharma. Gabapentin.

As of Nov 14, 2026, ANDA 203244 (Gabapentin), held by Strides Pharma, was first approved by FDA on Jul 12, 2013, with 9 approved supplements and 0 published complete response letters.

First approved: Jul 12, 2013
Supplements approved: 9
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 10 submissions below

Date	Submission	Status	Documents
Jul 12, 2013	Original application	Approved	None posted

Products

2 strengths and forms


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

All 10 submissions, including labeling and manufacturing supplements


Jun 4, 2025	Supplement 8Labeling · Standard review	Approved	None posted
Jun 4, 2025	Supplement 9Labeling · Standard review	Approved	None posted
Jun 4, 2025	Supplement 16Labeling · Standard review	Approved	None posted
Jun 4, 2025	Supplement 17Labeling · Standard review	Approved	None posted
Jun 4, 2025	Supplement 31Labeling · Standard review	Approved	None posted
Jun 4, 2025	Supplement 32Labeling · Standard review	Approved	None posted
Jun 4, 2025	Supplement 33Labeling · Standard review	Approved	None posted
Dec 28, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Dec 28, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Jul 12, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 203244
Drugs@FDA: Overview at FDA
Company: Strides Pharma Inc

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