Gabapentin

As of Nov 14, 2026, ANDA 75539 (Gabapentin), held by Sandoz, was first approved by FDA on Apr 6, 2005, with 7 approved supplements and 0 published complete response letters.

First approved: Apr 6, 2005
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Apr 6, 2005	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 8 submissions, including labeling and manufacturing supplements


Dec 17, 2025	Supplement 12Labeling · Standard review	Approved	None posted
Dec 19, 2024	Supplement 11Labeling · Standard review	Approved	None posted
Jul 16, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Jul 16, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Jul 16, 2024	Supplement 6Labeling · Standard review	Approved	None posted
Jul 16, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Jul 16, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Apr 6, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 75539
Drugs@FDA: Overview at FDA
Company: Sandoz

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