Gabapentin

ANDA 205807, held by Teva Pharms USA. Gabapentin.

As of Nov 14, 2026, ANDA 205807 (Gabapentin), held by Teva Pharms USA, was first approved by FDA on Mar 10, 2017, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 10, 2017
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Mar 10, 2017	Original application	Approved	None posted

Products

2 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


May 1, 2026	Supplement 2Labeling · Standard review	Approved	None posted
May 1, 2026	Supplement 3Labeling · Standard review	Approved	None posted
Mar 10, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 205807
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals USA

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