Gabapentin

ANDA 78150, held by Hikma. Gabapentin.

As of Nov 14, 2026, ANDA 78150 (Gabapentin), held by Hikma, was first approved by FDA on Sep 25, 2007, with 10 approved supplements and 0 published complete response letters.

First approved: Sep 25, 2007
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Sep 25, 2007	Original application	Approved	None posted

Products

3 strengths and forms


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

All 11 submissions, including labeling and manufacturing supplements


Aug 2, 2023	Supplement 18Labeling · Standard review	Approved	None posted
Aug 10, 2020	Supplement 16Labeling · Standard review	Approved	None posted
Aug 10, 2020	Supplement 17Labeling · Standard review	Approved	None posted
Jul 20, 2012	Supplement 14Manufacturing	Approved	None posted
Apr 30, 2012	Supplement 13Labeling	Approved	None posted
Apr 5, 2012	Supplement 8Manufacturing	Approved	None posted
Apr 5, 2012	Supplement 10Manufacturing	Approved	None posted
Nov 25, 2011	Supplement 12Labeling	Approved	None posted
Aug 29, 2011	Supplement 9Labeling	Approved	None posted
Nov 18, 2009	Supplement 2Labeling	Approved	None posted
Sep 25, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78150
Drugs@FDA: Overview at FDA
Company: Hikma

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