APPLICATION
NDA007750
TYPE
NDA
ORIGINAL APPROVAL
1950-12-04
LATEST ACTION
1996-03-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CORTONE · ReferenceDiscontinued
CORTISONE ACETATE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
1996-03-01Manufacturing (CMC) · Supplement 29 · standardAP
1994-08-18Manufacturing (CMC) · Supplement 27 · standardAP
1993-08-27Labeling · Supplement 25 · standardAP
1989-11-30Manufacturing (CMC) · Supplement 24 · standardAP
1989-05-16Labeling · Supplement 18 · standardAP
1982-03-02Manufacturing (CMC) · Supplement 17 · standardAP
1980-02-01Labeling · Supplement 13 · standardAP
1979-09-25Labeling · Supplement 12 · standardAP
1979-08-01Labeling · Supplement 11 · standardAP
1950-12-04Type 3 - New Dosage Form · Original · 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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