Gabapentin

Manages postherpetic neuralgia. ANDA 90705, held by Invagen Pharms. Gabapentin.

As of Nov 14, 2026, ANDA 90705 (Gabapentin), held by Invagen Pharms, was first approved by FDA on Dec 30, 2009, with 13 approved supplements and 0 published complete response letters.

First approved: Dec 30, 2009
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Gabapentin capsules 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 14 submissions below

Date	Submission	Status	Documents
Dec 30, 2009	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 14 submissions, including labeling and manufacturing supplements


Sep 11, 2026	Supplement 38Labeling · Standard review	Approved	None posted
May 22, 2025	Supplement 37Labeling · Standard review	Approved	None posted
Apr 18, 2023	Supplement 31Labeling · Standard review	Approved	None posted
Sep 8, 2020	Supplement 17Labeling · Standard review	Approved	None posted
Sep 8, 2020	Supplement 18Labeling · Standard review	Approved	None posted
Sep 8, 2020	Supplement 27Labeling · Standard review	Approved	None posted
Feb 3, 2016	Supplement 9Labeling · Standard review	Approved	None posted
Feb 3, 2016	Supplement 11Labeling · Standard review	Approved	None posted
Feb 3, 2016	Supplement 12Labeling · Standard review	Approved	None posted
Oct 30, 2014	Supplement 8Labeling · Standard review	Approved	None posted
Apr 11, 2012	Supplement 4Labeling	Approved	None posted
Dec 15, 2011	Supplement 3Labeling	Approved	None posted
Aug 29, 2011	Supplement 1Labeling	Approved	None posted
Dec 30, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 90705
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