Gabapentin

ANDA 75485, held by Watson Labs. Gabapentin.

As of Nov 14, 2026, ANDA 75485 (Gabapentin), held by Watson Labs, was first approved by FDA on May 11, 2007, with 1 approved supplement and 0 published complete response letters.

First approved: May 11, 2007
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
May 11, 2007	Original application	Approved	None posted

Products

3 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Mar 14, 2025	Supplement 1Labeling · Standard review	Approved	None posted
May 11, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 75485
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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