APPLICATION
ANDA074615
TYPE
ANDA
ORIGINAL APPROVAL
1995-09-29
LATEST ACTION
2009-04-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GEMFIBROZILDiscontinued
GEMFIBROZIL 600MG · TABLET · ORAL
Approval history
2009-04-08Labeling · Supplement 7AP
1997-12-12Manufacturing (CMC) · Supplement 4AP
1996-02-22Labeling · Supplement 2AP
1996-02-22Manufacturing (CMC) · Supplement 1AP
1996-01-25Manufacturing (CMC) · Supplement 3AP
1995-09-29OriginalAP
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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