Gabapentin

ANDA 90158, held by Pharmazone. Gabapentin.

As of Nov 14, 2026, ANDA 90158 (Gabapentin), held by Pharmazone, was first approved by FDA on Feb 14, 2011, with 8 approved supplements and 0 published complete response letters.

First approved: Feb 14, 2011
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Feb 14, 2011	Original application	Approved	None posted

Products

3 strengths and forms


Gabapentin100MG · capsule;oral	Gabapentin	Discontinued
Gabapentin300MG · capsule;oral	Gabapentin	Discontinued
Gabapentin400MG · capsule;oral	Gabapentin	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Mar 28, 2023	Supplement 11Labeling · Standard review	Approved	None posted
Sep 8, 2020	Supplement 5Labeling · Standard review	Approved	None posted
Sep 8, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Sep 8, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Sep 8, 2020	Supplement 9Labeling · Standard review	Approved	None posted
Sep 8, 2020	Supplement 10Labeling · Standard review	Approved	None posted
May 4, 2015	Supplement 2Labeling · Standard review	Approved	None posted
May 4, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Feb 14, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 90158
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