APPLICATION
NDA016099
TYPE
NDA
ORIGINAL APPROVAL
1967-02-08
LATEST ACTION
1998-07-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
ATROMID-SDiscontinued
CLOFIBRATE 500MG · CAPSULE · ORAL
Approval history
1998-07-07Manufacturing (CMC) · Supplement 61 · priorityAP
1996-04-08Labeling · Supplement 60 · priorityAP
1995-03-24Labeling · Supplement 59 · priorityAP
1994-07-27Manufacturing (CMC) · Supplement 57 · priorityAP
1994-04-19Labeling · Supplement 58 · priorityAP
1994-03-11Manufacturing (CMC) · Supplement 55 · priorityAP
1991-09-05Labeling · Supplement 56 · priorityAP
1990-04-25Labeling · Supplement 52 · priorityAP
1989-09-26Manufacturing (CMC) · Supplement 54 · priorityAP
1987-07-15Manufacturing (CMC) · Supplement 53 · priorityAP
1986-11-19Manufacturing (CMC) · Supplement 51 · priorityAP
1983-09-01REMS · Supplement 46 · priorityAP
1978-08-23Labeling · Supplement 29 · priorityAP
1967-02-08Type 1 - New Molecular Entity · Original · priorityAP
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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