APPLICATION
ANDA078012
TYPE
ANDA
ORIGINAL APPROVAL
2007-03-26
LATEST ACTION
2022-08-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GEMFIBROZILPrescription
GEMFIBROZIL 600MG · TABLET · ORAL
Approval history
2022-08-30Labeling · Supplement 19 · standardAP
2018-12-13Labeling · Supplement 17 · standardAP
2017-09-18Labeling · Supplement 12 · standardAP
2016-10-03Labeling · Supplement 10 · standardAP
2015-05-14Labeling · Supplement 7 · standardAP
2015-05-14Labeling · Supplement 8 · standardAP
2012-11-30Manufacturing (CMC) · Supplement 6AP
2007-03-26OriginalAP
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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