Gabapentin

ANDA 209855, held by Ipca Labs Ltd. Gabapentin.

As of Nov 14, 2026, ANDA 209855 (Gabapentin), held by Ipca Labs Ltd, was first approved by FDA on May 29, 2024, with 2 approved supplements and 0 published complete response letters.

First approved: May 29, 2024
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
May 29, 2024	Original application	Approved	None posted

Products

2 strengths and forms


Gabapentin600MG · tablet;oral	Gabapentin	Discontinued
Gabapentin800MG · tablet;oral	Gabapentin	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Feb 24, 2026	Supplement 2Labeling · Standard review	Approved	None posted
Oct 11, 2024	Supplement 1Labeling · Standard review	Approved	None posted
May 29, 2024	Original application	Approved	None posted

Identifiers

Application: ANDA 209855
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