Gabapentin

ANDA 75694, held by Actavis Elizabeth. Gabapentin.

As of Nov 14, 2026, ANDA 75694 (Gabapentin), held by Actavis Elizabeth, was first approved by FDA on Oct 21, 2004, with 17 approved supplements and 0 published complete response letters.

First approved: Oct 21, 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
Oct 21, 2004	Original application	Approved	None posted

Products

2 strengths and forms


Gabapentin600MG · tablet;oral	Gabapentin	Discontinued
Gabapentin800MG · tablet;oral	Gabapentin	Discontinued

All 18 submissions, including labeling and manufacturing supplements


Sep 12, 2025	Supplement 57Labeling · Standard review	Approved	None posted
Dec 17, 2024	Supplement 56Labeling · Standard review	Approved	None posted
Jul 19, 2022	Supplement 53Labeling · Standard review	Approved	None posted
Jul 19, 2022	Supplement 50Labeling · Standard review	Approved	None posted
Jul 19, 2022	Supplement 49Labeling · Standard review	Approved	None posted
Jul 19, 2022	Supplement 43Labeling · Standard review	Approved	None posted
Jul 19, 2022	Supplement 42Labeling · Standard review	Approved	None posted
Jan 4, 2016	Supplement 37Labeling · Standard review	Approved	None posted
Jan 4, 2016	Supplement 34Labeling · Standard review	Approved	None posted
Jan 4, 2016	Supplement 30Manufacturing	Approved	None posted
Nov 3, 2014	Supplement 31Labeling · Standard review	Approved	None posted
Apr 11, 2012	Supplement 24Labeling	Approved	None posted
Aug 29, 2011	Supplement 21Labeling	Approved	None posted
Mar 30, 2011	Supplement 20REMS	Approved	None posted
Nov 18, 2009	Supplement 16Labeling	Approved	None posted
Dec 23, 2005	Supplement 5Labeling	Approved	None posted
May 17, 2005	Supplement 1Labeling	Approved	None posted
Oct 21, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 75694
Drugs@FDA: Overview at FDA
Company: Actavis Elizabeth

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