Gabapentin

ANDA 76017, held by Ivax Sub Teva Pharms. Gabapentin.

As of Nov 14, 2026, ANDA 76017 (Gabapentin), held by Ivax Sub Teva Pharms, was first approved by FDA on Apr 28, 2004, with 17 approved supplements and 0 published complete response letters.

First approved: Apr 28, 2004
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Apr 28, 2004	Original application	Approved	Letter

Products

5 strengths and forms


Gabapentin100MG · tablet;oral	Gabapentin	Rx
Gabapentin300MG · tablet;oral	Gabapentin	Rx
Gabapentin400MG · tablet;oral	Gabapentin	Rx
Gabapentin600MG · tablet;oral	Gabapentin	Discontinued
Gabapentin800MG · tablet;oral	Gabapentin	Discontinued

All 18 submissions, including labeling and manufacturing supplements


Jul 20, 2015	Supplement 38Labeling · Standard review	Approved	None posted
Jul 20, 2015	Supplement 39Labeling · Standard review	Approved	None posted
Sep 25, 2014	Supplement 37Labeling · Standard review	Approved	None posted
Jul 19, 2012	Supplement 35Labeling · Standard review	Approved	None posted
Apr 16, 2012	Supplement 34Labeling	Approved	None posted
Sep 29, 2011	Supplement 33Labeling	Approved	None posted
Aug 25, 2011	Supplement 30Labeling	Approved	None posted
Nov 18, 2009	Supplement 25Labeling	Approved	None posted
Jul 14, 2008	Supplement 24Labeling	Approved	None posted
Apr 28, 2008	Supplement 22Labeling	Approved	None posted
Jan 17, 2008	Supplement 20Labeling	Approved	None posted
Dec 20, 2005	Supplement 12Labeling	Approved	None posted
Apr 29, 2005	Supplement 4	Approved	None posted
Apr 29, 2005	Supplement 5	Approved	None posted
Apr 29, 2005	Supplement 6Labeling	Approved	None posted
Apr 29, 2005	Supplement 9	Approved	None posted
Sep 20, 2004	Supplement 2Labeling	Approved	None posted
Apr 28, 2004	Original application	Approved	Letter

Identifiers

Application: ANDA 76017
Drugs@FDA: Overview at FDA
Company: IVAX 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