Glucophage

NDA 20357, held by Emd Serono Inc. Metformin Hydrochloride.

As of Nov 13, 2026, NDA 20357 (Glucophage), held by Emd Serono Inc, was first approved by FDA on Mar 3, 1995, with 30 approved supplements and 0 published complete response letters.

First approved: Mar 3, 1995
Review: Priority
Supplements approved: 30
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 31 submissions below


Apr 19, 2001	Supplement 20Efficacy (new indication or use) · Standard review	Approved	Review Letter
Dec 15, 2000	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Letter Review Label
Sep 22, 1999	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Review
Oct 22, 1998	Supplement 10Efficacy (new indication or use) · Priority review	Approved	Letter Review
Mar 3, 1995	Original applicationNew molecular entity · Priority review	Approved	Review

Products

5 strengths and forms


Glucophage500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Metformin Hydrochloride	DiscontinuedReference drug
Glucophage850MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Metformin Hydrochloride	DiscontinuedReference drug
Glucophage625MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Metformin Hydrochloride	DiscontinuedReference drug
Glucophage750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Metformin Hydrochloride	DiscontinuedReference drug
Glucophage1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Metformin Hydrochloride	DiscontinuedReference drug

All 31 submissions, including labeling and manufacturing supplements


May 30, 2018	Supplement 34Labeling	Approved	Letter Label
Apr 5, 2017	Supplement 39Labeling	Approved	Letter Label
Apr 5, 2017	Supplement 37Labeling · Standard review	Approved	Letter Label
Nov 13, 2013	Supplement 36Manufacturing · Priority review	Approved	None posted
Mar 14, 2013	Supplement 35Manufacturing · Priority review	Approved	None posted
Aug 27, 2008	Supplement 31Labeling · Standard review	Approved	Label Letter
Nov 1, 2006	Supplement 30Labeling · Standard review	Approved	Letter Label
Mar 19, 2004	Supplement 27Labeling · Standard review	Approved	Letter
Mar 19, 2004	Supplement 26Labeling · Standard review	Approved	Letter
Jan 8, 2002	Supplement 24Labeling · Standard review	Approved	Letter
Apr 19, 2001	Supplement 20Efficacy (new indication or use) · Standard review	Approved	Review Letter
Feb 8, 2001	Supplement 22Labeling · Standard review	Approved	None posted
Dec 15, 2000	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Letter Review Label
Aug 4, 2000	Supplement 21Manufacturing · Priority review	Approved	None posted
Sep 22, 1999	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Review
Jun 7, 1999	Supplement 18Manufacturing · Priority review	Approved	None posted
Jun 1, 1999	Supplement 15Manufacturing · Priority review	Approved	None posted
Mar 12, 1999	Supplement 16Manufacturing · Priority review	Approved	None posted
Dec 4, 1998	Supplement 14Manufacturing · Priority review	Approved	None posted
Nov 18, 1998	Supplement 13Manufacturing · Priority review	Approved	None posted
Nov 5, 1998	Supplement 11Manufacturing · Priority review	Approved	None posted
Oct 22, 1998	Supplement 10Efficacy (new indication or use) · Priority review	Approved	Letter Review
Jul 2, 1998	Supplement 9Manufacturing · Priority review	Approved	None posted
May 15, 1998	Supplement 7Manufacturing · Priority review	Approved	None posted
Feb 10, 1998	Supplement 8Labeling · Standard review	Approved	None posted
Nov 6, 1997	Supplement 6Labeling · Standard review	Approved	Review
Jun 6, 1997	Supplement 5Manufacturing · Priority review	Approved	None posted
Jul 26, 1996	Supplement 4Manufacturing · Priority review	Approved	None posted
Apr 30, 1996	Supplement 3Manufacturing · Priority review	Approved	None posted
Sep 13, 1995	Supplement 2Manufacturing · Priority review	Approved	None posted
Mar 3, 1995	Original applicationNew molecular entity · Priority review	Approved	Review

Identifiers

Application: NDA 20357
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