Gabapentin

ANDA 76537, held by Sun Pharm Industries. Gabapentin.

As of Nov 14, 2026, ANDA 76537 (Gabapentin), held by Sun Pharm Industries, was first approved by FDA on Jun 30, 2005, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 30, 2005
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jun 30, 2005	Original application	Approved	None posted

Products

3 strengths and forms


Gabapentin100MG · capsule;oral	Gabapentin	Discontinued
Gabapentin300MG · capsule;oral	Gabapentin	Discontinued
Gabapentin400MG · capsule;oral	Gabapentin	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Sep 29, 2006	Supplement 4Labeling	Approved	None posted
Jun 30, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 76537
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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