APPLICATION
ANDA074550
TYPE
ANDA
ORIGINAL APPROVAL
1997-09-11
LATEST ACTION
2017-03-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GLIPIZIDEDiscontinued
GLIPIZIDE 10MG · TABLET · ORAL
GLIPIZIDEDiscontinued
GLIPIZIDE 5MG · TABLET · ORAL
Approval history
2017-03-22Labeling · Supplement 11 · standardAP
2015-08-10Labeling · Supplement 10 · standardAP
2011-07-28Labeling · Supplement 8AP
2010-11-18Labeling · Supplement 6AP
2002-05-08Manufacturing (CMC) · Supplement 5AP
2002-05-08Manufacturing (CMC) · Supplement 4AP
2001-08-15Manufacturing (CMC) · Supplement 3AP
2000-01-28Manufacturing (CMC) · Supplement 2AP
1999-07-07Manufacturing (CMC) · Supplement 1AP
1997-09-11OriginalAP
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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