← FDA DRUG APPROVALS

FDA NDA · NDA020357

GLUCOPHAGE

Sponsor: EMD SERONO INC

APPLICATION
NDA020357
TYPE
NDA
ORIGINAL APPROVAL
1995-03-03
LATEST ACTION
2018-05-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

GLUCOPHAGE · ReferenceDiscontinued
METFORMIN HYDROCHLORIDE 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
GLUCOPHAGE · ReferenceDiscontinued
METFORMIN HYDROCHLORIDE 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
GLUCOPHAGE · ReferenceDiscontinued
METFORMIN HYDROCHLORIDE 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
GLUCOPHAGE · ReferenceDiscontinued
METFORMIN HYDROCHLORIDE 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
GLUCOPHAGE · ReferenceDiscontinued
METFORMIN HYDROCHLORIDE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2018-05-30Labeling · Supplement 34 · unknown — Letter ↗AP
2017-04-05Labeling · Supplement 39 · 901 required — Label ↗AP
2017-04-05Labeling · Supplement 37 · standard — Label ↗AP
2013-11-13Manufacturing (CMC) · Supplement 36 · priorityAP
2013-03-14Manufacturing (CMC) · Supplement 35 · priorityAP
2008-08-27Labeling · Supplement 31 · standard — Letter ↗AP
2006-11-01Labeling · Supplement 30 · standard — Letter ↗AP
2004-03-19Labeling · Supplement 26 · standard — Letter ↗AP
2004-03-19Labeling · Supplement 27 · standard — Letter ↗AP
2002-01-08Labeling · Supplement 24 · standard — Letter ↗AP
2001-04-19Efficacy · Supplement 20 · standard — Review ↗AP
2001-02-08Labeling · Supplement 22 · standardAP
2000-12-15Efficacy · Supplement 19 · standard — Review ↗AP
2000-08-04Manufacturing (CMC) · Supplement 21 · priorityAP
1999-09-22Efficacy · Supplement 17 · standard — Review ↗AP
1999-06-07Manufacturing (CMC) · Supplement 18 · priorityAP
1999-06-01Manufacturing (CMC) · Supplement 15 · priorityAP
1999-03-12Manufacturing (CMC) · Supplement 16 · priorityAP
1998-12-04Manufacturing (CMC) · Supplement 14 · priorityAP
1998-11-18Manufacturing (CMC) · Supplement 13 · priorityAP
1998-11-05Manufacturing (CMC) · Supplement 11 · priorityAP
1998-10-22Efficacy · Supplement 10 · priority — Review ↗AP
1998-07-02Manufacturing (CMC) · Supplement 9 · priorityAP
1998-05-15Manufacturing (CMC) · Supplement 7 · priorityAP
1998-02-10Labeling · Supplement 8 · standardAP
1997-11-06Labeling · Supplement 6 · standard — Review ↗AP
1997-06-06Manufacturing (CMC) · Supplement 5 · priorityAP
1996-07-26Manufacturing (CMC) · Supplement 4 · priorityAP
1996-04-30Manufacturing (CMC) · Supplement 3 · priorityAP
1995-09-13Manufacturing (CMC) · Supplement 2 · priorityAP
1995-03-03Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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