Fortamet

NDA 21574, held by Andrx Labs LLC. Metformin Hydrochloride.

As of Nov 15, 2026, NDA 21574 (Fortamet), held by Andrx Labs LLC, was first approved by FDA on Apr 27, 2004, with 7 approved supplements and 0 published complete response letters.

First approved: Apr 27, 2004
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Apr 27, 2004	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Products

2 strengths and forms


Fortamet500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Metformin Hydrochloride	DiscontinuedReference drug
Fortamet1GM · tablet, extended release;oral	Metformin Hydrochloride	DiscontinuedReference drug

All 8 submissions, including labeling and manufacturing supplements


Aug 11, 2026	Supplement 32Labeling	Approved	Label Letter
Nov 8, 2018	Supplement 17Labeling · Standard review	Approved	Letter Label
Apr 5, 2017	Supplement 20Labeling	Approved	Letter Label
May 18, 2015	Supplement 18Manufacturing · Standard review	Approved	None posted
Jul 29, 2008	Supplement 10Labeling · Standard review	Approved	Label Letter
Apr 19, 2007	Supplement 6Labeling · Standard review	Approved	Letter Label
Feb 8, 2006	Supplement 5Labeling · Standard review	Approved	Letter
Apr 27, 2004	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21574
Drugs@FDA: Overview at FDA
Company: Andrx 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