Gabapentin

As of Nov 14, 2026, ANDA 77894 (Gabapentin), held by Apotex, was first approved by FDA on Oct 10, 2006, with 11 approved supplements and 0 published complete response letters.

First approved: Oct 10, 2006
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 10, 2006	Original application	Approved	None posted

Products

3 strengths and forms


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

All 12 submissions, including labeling and manufacturing supplements


Sep 16, 2025	Supplement 13Labeling · Standard review	Approved	None posted
Mar 6, 2025	Supplement 12Labeling · Standard review	Approved	None posted
Aug 2, 2023	Supplement 11Labeling · Standard review	Approved	None posted
Oct 26, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Oct 26, 2020	Supplement 9Labeling · Standard review	Approved	None posted
Oct 26, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Oct 26, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Sep 17, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Apr 17, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Apr 17, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Aug 11, 2010	Supplement 2Labeling	Approved	None posted
Oct 10, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 77894
Drugs@FDA: Overview at FDA
Company: Apotex

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