Glucophage Xr

NDA 21202, held by Emd Serono Inc. Metformin Hydrochloride.

As of Nov 14, 2026, NDA 21202 (Glucophage Xr), held by Emd Serono Inc, was first approved by FDA on Oct 13, 2000, with 16 approved supplements and 0 published complete response letters.

First approved: Oct 13, 2000
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Oct 13, 2000	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Glucophage Xr500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Metformin Hydrochloride	DiscontinuedReference drug
Glucophage Xr750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Metformin Hydrochloride	DiscontinuedReference drug

All 17 submissions, including labeling and manufacturing supplements


May 30, 2018	Supplement 18Labeling	Approved	Letter Label
Apr 5, 2017	Supplement 21Labeling · Standard review	Approved	Letter Label
Apr 5, 2017	Supplement 23Labeling	Approved	Letter Label
Mar 5, 2014	Supplement 20Manufacturing · Standard review	Approved	None posted
Jan 31, 2014	Supplement 19Manufacturing · Standard review	Approved	None posted
Aug 27, 2008	Supplement 16Labeling · Standard review	Approved	Label Letter
Nov 1, 2006	Supplement 15Labeling · Standard review	Approved	Letter Label
Mar 19, 2004	Supplement 11Labeling · Standard review	Approved	Letter
Mar 19, 2004	Supplement 13Labeling · Standard review	Approved	Letter
Apr 11, 2003	Supplement 8Manufacturing · Standard review	Approved	Letter Label
Jul 2, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
Jun 6, 2002	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 8, 2002	Supplement 3Labeling · Standard review	Approved	Letter
Jan 8, 2002	Supplement 4Manufacturing · Standard review	Approved	None posted
Jul 31, 2001	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 19, 2001	Supplement 1Labeling · Standard review	Approved	Letter
Oct 13, 2000	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21202
Drugs@FDA: Overview at FDA
Company: EMD Serono, Inc.

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