APPLICATION
ANDA077836
TYPE
ANDA
ORIGINAL APPROVAL
2006-07-27
LATEST ACTION
2022-08-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GEMFIBROZILPrescription
GEMFIBROZIL 600MG · TABLET · ORAL
Approval history
2022-08-17Labeling · Supplement 19 · standardAP
2019-11-26Labeling · Supplement 14 · standardAP
2017-10-02Labeling · Supplement 12 · standardAP
2017-10-02Labeling · Supplement 10 · standardAP
2016-01-21Labeling · Supplement 9 · standardAP
2010-11-23Labeling · Supplement 4AP
2010-01-11Labeling · Supplement 3AP
2006-07-27OriginalAP
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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