← FDA DRUG APPROVALS

FDA NDA · NDA021460

METAGLIP

Sponsor: BRISTOL MYERS SQUIBB

APPLICATION
NDA021460
TYPE
NDA
ORIGINAL APPROVAL
2002-10-21
LATEST ACTION
2013-10-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

METAGLIP · ReferenceDiscontinued
GLIPIZIDE 2.5MG, METFORMIN HYDROCHLORIDE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
METAGLIP · ReferenceDiscontinued
GLIPIZIDE 5MG, METFORMIN HYDROCHLORIDE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
METAGLIP · ReferenceDiscontinued
GLIPIZIDE 2.5MG, METFORMIN HYDROCHLORIDE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2013-10-15Labeling · Supplement 10 · standard — Label ↗AP
2011-02-01Labeling · Supplement 9 · standard — Label ↗AP
2009-08-07Labeling · Supplement 8 · standard — Letter ↗AP
2008-08-18Labeling · Supplement 7 · standard — Letter ↗AP
2007-06-18Labeling · Supplement 5 · standard — Letter ↗AP
2002-10-21Type 4 - New Combination · 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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