Gabapentin

Manages postherpetic neuralgia. ANDA 213603, held by Zhejiang Yongtai. Gabapentin.

As of Nov 14, 2026, ANDA 213603 (Gabapentin), held by Zhejiang Yongtai, was first approved by FDA on Aug 17, 2020, with 3 approved supplements and 0 published complete response letters.

First approved: Aug 17, 2020
Review: Standard
Supplements approved: 3
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 4 submissions below

Date	Submission	Status	Documents
Aug 17, 2020	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 4 submissions, including labeling and manufacturing supplements


May 1, 2026	Supplement 6Labeling · Standard review	Approved	None posted
May 1, 2026	Supplement 7Labeling · Standard review	Approved	None posted
Oct 11, 2023	Supplement 2Labeling · Standard review	Approved	None posted
Aug 17, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 213603
Drugs@FDA: Overview at FDA
Company: Zhejiang Yongtai

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