Gabapentin

ANDA 75435, held by Teva Pharms. Gabapentin.

As of Nov 14, 2026, ANDA 75435 (Gabapentin), held by Teva Pharms, was first approved by FDA on Oct 8, 2004, with 11 approved supplements and 0 published complete response letters.

First approved: Oct 8, 2004
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Oct 8, 2004	Original application	Approved	Letter

Products

3 strengths and forms


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

All 12 submissions, including labeling and manufacturing supplements


May 7, 2026	Supplement 29Labeling · Standard review	Approved	None posted
May 7, 2026	Supplement 30Labeling · Standard review	Approved	None posted
Jul 10, 2013	Supplement 18Labeling	Approved	None posted
Dec 30, 2011	Supplement 22Labeling	Approved	None posted
Dec 30, 2011	Supplement 23Labeling	Approved	None posted
Aug 29, 2011	Supplement 21Labeling	Approved	None posted
May 13, 2010	Supplement 20Labeling	Approved	None posted
Jul 14, 2009	Supplement 13Labeling	Approved	None posted
Oct 10, 2007	Supplement 7Labeling	Approved	None posted
Feb 22, 2007	Supplement 5Labeling	Approved	None posted
Apr 5, 2006	Supplement 3Labeling	Approved	None posted
Oct 8, 2004	Original application	Approved	Letter

Identifiers

Application: ANDA 75435
Drugs@FDA: Overview at FDA
Company: Teva 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