← FDA DRUG APPROVALS

FDA NDA · NDA021748

METFORMIN HYDROCHLORIDE

Sponsor: SANTARUS INC

APPLICATION
NDA021748
TYPE
NDA
ORIGINAL APPROVAL
2005-06-03
LATEST ACTION
2018-11-07
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

GLUMETZA · ReferenceDiscontinued
METFORMIN HYDROCHLORIDE 1GM · TABLET, EXTENDED RELEASE · ORAL
GLUMETZA · ReferenceDiscontinued
METFORMIN HYDROCHLORIDE 500MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2018-11-07Labeling · Supplement 25 · standard — Label ↗AP
2017-04-05Labeling · Supplement 20 · 901 required — Label ↗AP
2015-10-27Manufacturing (CMC) · Supplement 19 · standardAP
2011-04-13Labeling · Supplement 10 · standard — Label ↗AP
2010-02-25Labeling · Supplement 8 · standard — Letter ↗AP
2009-06-16Labeling · Supplement 5 · standard — Letter ↗AP
2007-12-28Manufacturing (CMC) · Supplement 4AP
2006-11-01Labeling · Supplement 2 · standard — Letter ↗AP
2005-06-03Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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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