Gabapentin

ANDA 75827, held by Teva. Gabapentin.

As of Nov 14, 2026, ANDA 75827 (Gabapentin), held by Teva, was first approved by FDA on Dec 15, 2004, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 15, 2004
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Dec 15, 2004	Original application	Approved	None posted

Products

2 strengths and forms


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

All 5 submissions, including labeling and manufacturing supplements


May 21, 2012	Supplement 9Labeling · Standard review	Approved	None posted
Apr 16, 2012	Supplement 8Labeling	Approved	None posted
Apr 10, 2006	Supplement 3Labeling	Approved	None posted
May 20, 2005	Supplement 1Labeling	Approved	None posted
Dec 15, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 75827
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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