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FDA ANDA · ANDA078083
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
Sponsor: NOVITIUM PHARMA
APPLICATION
ANDA078083
TYPE
ANDA
ORIGINAL APPROVAL
2007-04-12
LATEST ACTION
2017-04-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GLIPIZIDE AND METFORMIN HYDROCHLORIDEDiscontinued
GLIPIZIDE 5MG, METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
GLIPIZIDE AND METFORMIN HYDROCHLORIDEDiscontinued
GLIPIZIDE 2.5MG, METFORMIN HYDROCHLORIDE 250MG · TABLET · ORAL
GLIPIZIDE AND METFORMIN HYDROCHLORIDEDiscontinued
GLIPIZIDE 2.5MG, METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
Approval history
2017-04-05Labeling · Supplement 6 · standardAP
2015-10-02Labeling · Supplement 5 · standardAP
2015-10-02Labeling · Supplement 3 · standardAP
2009-06-17Labeling · Supplement 1AP
2007-04-12OriginalAP
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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