Gabapentin

ANDA 209306, held by Lupin. Gabapentin.

As of Nov 14, 2026, ANDA 209306 (Gabapentin), held by Lupin, was first approved by FDA on Aug 24, 2018, with 3 approved supplements and 0 published complete response letters.

First approved: Aug 24, 2018
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Aug 24, 2018	Original application	Approved	None posted

Products

2 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Sep 26, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Nov 12, 2021	Supplement 3Labeling · Standard review	Approved	None posted
Nov 12, 2021	Supplement 2Labeling · Standard review	Approved	None posted
Aug 24, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 209306
Drugs@FDA: Overview at FDA
Company: Lupin

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