APPLICATION
NDA018754
TYPE
NDA
ORIGINAL APPROVAL
1986-01-09
LATEST ACTION
2006-01-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
ORUDIS · ReferenceDiscontinued
KETOPROFEN 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
ORUDIS · ReferenceDiscontinued
KETOPROFEN 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
ORUDIS · ReferenceDiscontinued
KETOPROFEN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
Approval history
1995-02-17Manufacturing (CMC) · Supplement 20 · standardAP
1995-02-08Labeling · Supplement 24 · standardAP
1994-07-11Manufacturing (CMC) · Supplement 22 · standardAP
1994-07-11Manufacturing (CMC) · Supplement 23 · standardAP
1994-01-06Efficacy · Supplement 18 · standardAP
1990-09-05Manufacturing (CMC) · Supplement 10 · standardAP
1990-01-16Manufacturing (CMC) · Supplement 13 · standardAP
1989-10-05Manufacturing (CMC) · Supplement 14 · standardAP
1989-10-05Manufacturing (CMC) · Supplement 9 · standardAP
1989-04-10Manufacturing (CMC) · Supplement 6 · standardAP
1989-01-11Manufacturing (CMC) · Supplement 12 · standardAP
1988-10-26Manufacturing (CMC) · Supplement 15 · standardAP
1988-02-18Labeling · Supplement 11 · standardAP
1987-07-31Labeling · Supplement 4 · standardAP
1987-07-31Efficacy · Supplement 3 · standardAP
1987-07-23Labeling · Supplement 7 · standardAP
1987-03-17Manufacturing (CMC) · Supplement 2 · standardAP
1986-07-16Manufacturing (CMC) · Supplement 5 · standardAP
1986-01-27Labeling · Supplement 1 · standardAP
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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