APPLICATION
ANDA202726
TYPE
ANDA
ORIGINAL APPROVAL
2015-09-16
LATEST ACTION
2021-12-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GEMFIBROZILPrescription
GEMFIBROZIL 600MG · TABLET · ORAL
Approval history
2021-12-10Labeling · Supplement 10 · standardAP
2019-02-19Labeling · Supplement 6 · standardAP
2017-09-18Labeling · Supplement 5 · standardAP
2016-10-03Labeling · Supplement 3 · standardAP
2015-09-16UNKNOWN · OriginalAP
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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