Gabapentin

Manages postherpetic neuralgia. ANDA 205101, held by Sciegen Pharms. Gabapentin.

As of Nov 14, 2026, ANDA 205101 (Gabapentin), held by Sciegen Pharms, was first approved by FDA on Feb 4, 2016, with 10 approved supplements and 0 published complete response letters.

First approved: Feb 4, 2016
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Gabapentin 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 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
Feb 4, 2016	Original application	Approved	Letter

Products

2 strengths and forms


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

All 11 submissions, including labeling and manufacturing supplements


Feb 17, 2026	Supplement 29Labeling · Standard review	Approved	None posted
Dec 31, 2024	Supplement 19Labeling · Standard review	Approved	None posted
Dec 31, 2024	Supplement 25Labeling · Standard review	Approved	None posted
Dec 31, 2024	Supplement 28Labeling · Standard review	Approved	None posted
Sep 29, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Sep 29, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Sep 29, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Sep 29, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Sep 29, 2020	Supplement 18Labeling · Standard review	Approved	None posted
Dec 27, 2017	Supplement 5Manufacturing	Approved	None posted
Feb 4, 2016	Original application	Approved	Letter

Identifiers

Application: ANDA 205101
Drugs@FDA: Overview at FDA
Company: ScieGen 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