Gabapentin

ANDA 90335, held by Pharmobedient. Gabapentin.

As of Nov 14, 2026, ANDA 90335 (Gabapentin), held by Pharmobedient, was first approved by FDA on Jun 1, 2010, with 9 approved supplements and 0 published complete response letters.

First approved: Jun 1, 2010
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Jun 1, 2010	Original application	Approved	None posted

Products

2 strengths and forms


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

All 10 submissions, including labeling and manufacturing supplements


May 23, 2023	Supplement 11Labeling · Standard review	Approved	None posted
May 23, 2023	Supplement 10Labeling · Standard review	Approved	None posted
May 23, 2023	Supplement 9Labeling · Standard review	Approved	None posted
May 23, 2023	Supplement 8Labeling · Standard review	Approved	None posted
May 23, 2023	Supplement 6Labeling · Standard review	Approved	None posted
May 23, 2023	Supplement 5Labeling · Standard review	Approved	None posted
May 23, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Nov 29, 2012	Supplement 3Labeling · Standard review	Approved	None posted
Aug 4, 2011	Supplement 1REMS	Approved	None posted
Jun 1, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 90335
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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