Gabapentin

Manages postherpetic neuralgia. ANDA 202764, held by Invagen Pharms. Gabapentin.

As of Nov 14, 2026, ANDA 202764 (Gabapentin), held by Invagen Pharms, was first approved by FDA on Oct 16, 2012, with 7 approved supplements and 0 published complete response letters.

First approved: Oct 16, 2012
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Gabapentin Tablets, USP 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 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 8 submissions below

Date	Submission	Status	Documents
Oct 16, 2012	Original application	Approved	None posted

Products

2 strengths and forms


Gabapentin600MG · tablet;oral	Gabapentin	Discontinued
Gabapentin800MG · tablet;oral	Gabapentin	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Jun 2, 2021	Supplement 6Labeling · Standard review	Approved	None posted
Jun 2, 2021	Supplement 7Labeling · Standard review	Approved	None posted
Jun 2, 2021	Supplement 8Labeling · Standard review	Approved	None posted
Jun 2, 2021	Supplement 21Labeling · Standard review	Approved	None posted
Jun 2, 2021	Supplement 24Labeling · Standard review	Approved	None posted
Jun 2, 2021	Supplement 25Labeling · Standard review	Approved	None posted
Sep 25, 2014	Supplement 4Labeling · Standard review	Approved	None posted
Oct 16, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 202764
Drugs@FDA: Overview at FDA
Company: InvaGen Pharmaceuticals, 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