Gabapentin

Manages postherpetic neuralgia. ANDA 214957, held by Ascent Pharms Inc. Gabapentin.

As of Nov 14, 2026, ANDA 214957 (Gabapentin), held by Ascent Pharms Inc, was first approved by FDA on Oct 1, 2021, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 1, 2021
Review: Standard
Supplements approved: 2
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 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 3 submissions below

Date	Submission	Status	Documents
Oct 1, 2021	Original application	Approved	None posted

Products

2 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Apr 28, 2026	Supplement 5Labeling · Standard review	Approved	None posted
Apr 28, 2026	Supplement 7Labeling · Standard review	Approved	None posted
Oct 1, 2021	Original application	Approved	None posted

Identifiers

Application: ANDA 214957
Drugs@FDA: Overview at FDA
Company: Ascent 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