Gabapentin

ANDA 208928, held by Ipca Labs Ltd. Gabapentin.

As of Nov 14, 2026, ANDA 208928 (Gabapentin), held by Ipca Labs Ltd, was first approved by FDA on Nov 20, 2023, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 20, 2023
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Nov 20, 2023	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 3 submissions, including labeling and manufacturing supplements


Feb 18, 2026	Supplement 2Labeling · Standard review	Approved	None posted
Oct 15, 2024	Supplement 1Labeling · Standard review	Approved	None posted
Nov 20, 2023	Original application	Approved	None posted

Identifiers

Application: ANDA 208928
Drugs@FDA: Overview at FDA
Company: Ipca 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