Gabapentin

ANDA 76606, held by Sun Pharm Inds Ltd. Gabapentin.

As of Nov 14, 2026, ANDA 76606 (Gabapentin), held by Sun Pharm Inds Ltd, was first approved by FDA on Oct 7, 2005, with 3 approved supplements and 0 published complete response letters.

First approved: Oct 7, 2005
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Oct 7, 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 4 submissions, including labeling and manufacturing supplements


Sep 23, 2011	Supplement 9Labeling	Approved	None posted
May 13, 2010	Supplement 8Labeling	Approved	None posted
Aug 6, 2007	Supplement 5Labeling	Approved	None posted
Oct 7, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 76606
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