Gabapentin

ANDA 76120, held by Chartwell Rx. Gabapentin.

As of Nov 14, 2026, ANDA 76120 (Gabapentin), held by Chartwell Rx, was first approved by FDA on Jan 27, 2006, with 2 approved supplements and 0 published complete response letters.

First approved: Jan 27, 2006
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
Jan 27, 2006	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


Jul 8, 2022	Supplement 3Labeling · Standard review	Approved	None posted
Jul 8, 2022	Supplement 4Labeling · Standard review	Approved	None posted
Jan 27, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 76120
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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