Gabapentin

Manages postherpetic neuralgia. ANDA 207057, held by Cspc Ouyi. Gabapentin.

As of Nov 14, 2026, ANDA 207057 (Gabapentin), held by Cspc Ouyi, was first approved by FDA on Oct 26, 2017, with 4 approved supplements and 0 published complete response letters.

First approved: Oct 26, 2017
Review: Standard
Supplements approved: 4
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 5 submissions below

Date	Submission	Status	Documents
Oct 26, 2017	Original application	Approved	None posted

Products

2 strengths and forms


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

All 5 submissions, including labeling and manufacturing supplements


Dec 31, 2024	Supplement 1Labeling · Standard review	Approved	None posted
Dec 31, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Dec 31, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Dec 31, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Oct 26, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 207057
Drugs@FDA: Overview at FDA
Company: CSPC Ouyi

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