Gabapentin

ANDA 76877, held by Pharmazone. Gabapentin.

As of Nov 14, 2026, ANDA 76877 (Gabapentin), held by Pharmazone, was first approved by FDA on Jul 6, 2006, with 1 approved supplement and 0 published complete response letters.

First approved: Jul 6, 2006
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jul 6, 2006	Original application	Approved	None posted

Products

2 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Sep 24, 2014	Supplement 4Labeling · Standard review	Approved	None posted
Jul 6, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 76877
Drugs@FDA: Overview at FDA
Company: Pharmazone

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