Gabapentin

Manages postherpetic neuralgia. ANDA 207099, held by Rising. Gabapentin.

As of Nov 14, 2026, ANDA 207099 (Gabapentin), held by Rising, was first approved by FDA on Mar 24, 2017, with 5 approved supplements and 0 published complete response letters.

First approved: Mar 24, 2017
Review: Standard
Supplements approved: 5
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 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 6 submissions below

Date	Submission	Status	Documents
Mar 24, 2017	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 6 submissions, including labeling and manufacturing supplements


Jan 29, 2026	Supplement 20Labeling · Standard review	Approved	None posted
Sep 9, 2024	Supplement 18Labeling · Standard review	Approved	None posted
Feb 20, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Oct 2, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Oct 2, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Mar 24, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 207099
Drugs@FDA: Overview at FDA
Company: Rising 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