Gabapentin

Manages postherpetic neuralgia. ANDA 202024, held by Amneal Pharms. Gabapentin.

As of Nov 14, 2026, ANDA 202024 (Gabapentin), held by Amneal Pharms, was first approved by FDA on Mar 23, 2012, with 10 approved supplements and 0 published complete response letters.

First approved: Mar 23, 2012
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Gabapentin oral solution is 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 oral solution 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 11 submissions below

Date	Submission	Status	Documents
Mar 23, 2012	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gabapentin250MG/5ML · solution;oral	Gabapentin	Rx

All 11 submissions, including labeling and manufacturing supplements


Sep 16, 2025	Supplement 19Labeling · Standard review	Approved	None posted
Sep 16, 2025	Supplement 21Labeling · Standard review	Approved	None posted
May 29, 2024	Supplement 3Labeling · Standard review	Approved	None posted
May 29, 2024	Supplement 4Labeling · Standard review	Approved	None posted
May 29, 2024	Supplement 5Labeling · Standard review	Approved	None posted
May 29, 2024	Supplement 7Labeling · Standard review	Approved	None posted
May 29, 2024	Supplement 10Labeling · Standard review	Approved	None posted
May 29, 2024	Supplement 11Labeling · Standard review	Approved	None posted
Nov 8, 2014	Supplement 1Labeling · Standard review	Approved	None posted
Nov 8, 2014	Supplement 2Labeling · Standard review	Approved	None posted
Mar 23, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 202024
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals

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