Gabapentin

ANDA 78782, held by Hikma Pharms. Gabapentin.

As of Nov 14, 2026, ANDA 78782 (Gabapentin), held by Hikma Pharms, was first approved by FDA on Jul 21, 2011, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 21, 2011
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jul 21, 2011	Original application	Approved	None posted

Products

2 strengths and forms


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

All 6 submissions, including labeling and manufacturing supplements


Feb 29, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Feb 29, 2016	Supplement 5Labeling · Standard review	Approved	None posted
Feb 29, 2016	Supplement 6Labeling · Standard review	Approved	None posted
Nov 28, 2012	Supplement 2Labeling · Standard review	Approved	None posted
Apr 17, 2012	Supplement 1Labeling	Approved	None posted
Jul 21, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 78782
Drugs@FDA: Overview at FDA
Company: Hikma 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