APPLICATION
ANDA074270
TYPE
ANDA
ORIGINAL APPROVAL
1993-09-27
LATEST ACTION
2024-05-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GEMFIBROZILPrescription
GEMFIBROZIL 600MG · TABLET · ORAL
Approval history
2024-05-17Manufacturing (CMC) · Supplement 19 · unknownAP
2024-02-01Labeling · Supplement 18 · standardAP
2019-10-21Labeling · Supplement 17 · standardAP
2016-10-03Labeling · Supplement 16 · standardAP
2016-02-19Labeling · Supplement 15 · standardAP
2005-08-29Labeling · Supplement 5AP
1995-04-05Manufacturing (CMC) · Supplement 1AP
1994-10-07Manufacturing (CMC) · Supplement 2AP
1994-10-07Manufacturing (CMC) · Supplement 3AP
1993-09-27OriginalAP
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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