Gabapentin

As of Nov 14, 2026, ANDA 75428 (Gabapentin), held by Sandoz, was first approved by FDA on Jan 24, 2006, with 4 approved supplements and 0 published complete response letters.

First approved: Jan 24, 2006
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jan 24, 2006	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 5 submissions, including labeling and manufacturing supplements


Jul 16, 2026	Supplement 7Labeling · Standard review	Approved	None posted
Dec 16, 2024	Supplement 6Labeling · Standard review	Approved	None posted
Jul 8, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Jul 8, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Jan 24, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 75428
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