APPLICATION
NDA008126
TYPE
NDA
ORIGINAL APPROVAL
1951-11-02
LATEST ACTION
1994-12-21
ROUTE
ORAL, INJECTION
DOSAGE FORM
TABLET, INJECTABLE
MARKETING STATUS
Discontinued
Products
CORTISONE ACETATEDiscontinued
CORTISONE ACETATE 10MG · TABLET · ORAL
CORTISONE ACETATEDiscontinued
CORTISONE ACETATE 25MG/ML · INJECTABLE · INJECTION
CORTISONE ACETATEDiscontinued
CORTISONE ACETATE 5MG · TABLET · ORAL
CORTISONE ACETATEDiscontinued
CORTISONE ACETATE 25MG · TABLET · ORAL
Approval history
1994-12-21Manufacturing (CMC) · Supplement 38 · standardAP
1993-12-28Labeling · Supplement 35AP
1991-12-24Manufacturing (CMC) · Supplement 34 · standardAP
1978-02-08Labeling · Supplement 27AP
1977-05-16Manufacturing (CMC) · Supplement 25 · standardAP
1951-11-02Type 5 - New Formulation or New Manufacturer · 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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