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FDA ANDA · ANDA076731
GLYBURIDE AND METFORMIN HYDROCHLORIDE
Sponsor: IMPAX LABS INC
APPLICATION
ANDA076731
TYPE
ANDA
ORIGINAL APPROVAL
2004-11-19
LATEST ACTION
2015-05-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GLYBURIDE AND METFORMIN HYDROCHLORIDEDiscontinued
GLYBURIDE 5MG, METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
GLYBURIDE AND METFORMIN HYDROCHLORIDEDiscontinued
GLYBURIDE 1.25MG, METFORMIN HYDROCHLORIDE 250MG · TABLET · ORAL
GLYBURIDE AND METFORMIN HYDROCHLORIDEDiscontinued
GLYBURIDE 2.5MG, METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
Approval history
2015-05-08Labeling · Supplement 14 · standardAP
2011-08-18Labeling · Supplement 13AP
2010-09-30Labeling · Supplement 12AP
2010-05-13Labeling · Supplement 11AP
2009-09-18Labeling · Supplement 10AP
2006-07-03Labeling · Supplement 1AP
2004-11-19OriginalAP
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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