APPLICATION
ANDA079072
TYPE
ANDA
ORIGINAL APPROVAL
2010-09-13
LATEST ACTION
2021-03-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GEMFIBROZILPrescription
GEMFIBROZIL 600MG · TABLET · ORAL
Approval history
2021-03-08Labeling · Supplement 14 · standardAP
2018-12-11Labeling · Supplement 12 · standardAP
2018-12-11Labeling · Supplement 11 · standardAP
2016-09-28Labeling · Supplement 9 · standardAP
2015-09-15Labeling · Supplement 5 · standardAP
2015-09-15Labeling · Supplement 6 · standardAP
2013-01-07Labeling · Supplement 4 · standardAP
2011-02-16Labeling · Supplement 1AP
2010-09-13OriginalAP
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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