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FDA NDA · NDA021574

FORTAMET

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APPLICATION
NDA021574
TYPE
NDA
ORIGINAL APPROVAL
2004-04-27
LATEST ACTION
2018-11-08
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

FORTAMET · ReferenceDiscontinued
METFORMIN HYDROCHLORIDE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
FORTAMET · ReferenceDiscontinued
METFORMIN HYDROCHLORIDE 1GM · TABLET, EXTENDED RELEASE · ORAL

Approval history

2018-11-08Labeling · Supplement 17 · standard — Label ↗AP
2017-04-05Labeling · Supplement 20 · 901 required — Label ↗AP
2015-05-18Manufacturing (CMC) · Supplement 18 · standardAP
2008-07-29Labeling · Supplement 10 · standard — Label ↗AP
2007-04-19Labeling · Supplement 6 · standard — Label ↗AP
2006-02-08Labeling · Supplement 5 · standard — Letter ↗AP
2004-04-27Type 5 - New Formulation or New Manufacturer · Original · standard — 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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