Gabapentin

Manages postherpetic neuralgia. ANDA 90007, held by Pharmazone. Gabapentin.

As of Nov 14, 2026, ANDA 90007 (Gabapentin), held by Pharmazone, was first approved by FDA on Jul 21, 2011, with 9 approved supplements and 0 published complete response letters.

First approved: Jul 21, 2011
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Gabapentin Capsules, 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 Capsules 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 21, 2011	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 10 submissions, including labeling and manufacturing supplements


Aug 18, 2025	Supplement 13Labeling · Standard review	Approved	None posted
Aug 18, 2025	Supplement 14Labeling · Standard review	Approved	None posted
Mar 17, 2023	Supplement 9Labeling · Standard review	Approved	None posted
Aug 20, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Aug 20, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Aug 20, 2020	Supplement 5Labeling · Standard review	Approved	None posted
Aug 20, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Aug 20, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Nov 8, 2014	Supplement 2Labeling · Standard review	Approved	None posted
Jul 21, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 90007
Drugs@FDA: Overview at FDA
Company: Pharmazone

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