← FDA DRUG APPROVALS

FDA NDA · NDA021591

RIOMET

metformin hydrochloride

Sponsor: RANBAXY

APPLICATION
NDA021591
TYPE
NDA
ORIGINAL APPROVAL
2003-09-11
LATEST ACTION
2018-11-06
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

RIOMET · ReferenceDiscontinued
METFORMIN HYDROCHLORIDE 500MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL

Approval history

2018-11-06Labeling · Supplement 7 · standard — Label ↗AP
2017-04-05Labeling · Supplement 10 · 901 required — Label ↗AP
2014-08-29Manufacturing (CMC) · Supplement 8 · standardAP
2013-09-16Manufacturing (CMC) · Supplement 6 · standardAP
2010-12-06Labeling · Supplement 5 · unknown — Label ↗AP
2008-10-20Type 3 - New Dosage Form · Original · standardAP
2008-10-20Labeling · Supplement 4 · standard — Label ↗AP
2005-09-20Labeling · Supplement 3 · standard — Letter ↗AP
2004-06-02Labeling · Supplement 1 · standard — Letter ↗AP
2003-09-11Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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