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FDA ANDA · ANDA070531

CLOFIBRATE

Sponsor: USL PHARMA

APPLICATION
ANDA070531
TYPE
ANDA
ORIGINAL APPROVAL
1986-06-16
LATEST ACTION
1995-04-05
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

CLOFIBRATEDiscontinued
CLOFIBRATE 500MG · CAPSULE · ORAL

Approval history

1995-04-05Manufacturing (CMC) · Supplement 14AP
1995-04-05Manufacturing (CMC) · Supplement 13AP
1993-11-05Manufacturing (CMC) · Supplement 11AP
1993-11-05Manufacturing (CMC) · Supplement 8AP
1993-11-05Manufacturing (CMC) · Supplement 10AP
1993-11-05Manufacturing (CMC) · Supplement 9AP
1993-11-05Manufacturing (CMC) · Supplement 7AP
1992-04-22Labeling · Supplement 6AP
1990-10-10Labeling · Supplement 5AP
1989-10-06Labeling · Supplement 4AP
1989-06-19Labeling · Supplement 3AP
1988-12-15Labeling · Supplement 2AP
1986-06-16OriginalAP
VIEW ON DRUGS@FDA ↗

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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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