APPLICATION
NDA008228
TYPE
NDA
ORIGINAL APPROVAL
1951-12-21
LATEST ACTION
1996-03-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HYDROCORTONEDiscontinued
HYDROCORTISONE ACETATE 25MG/ML · INJECTABLE · INJECTION
HYDROCORTONEDiscontinued
HYDROCORTISONE ACETATE 50MG/ML · INJECTABLE · INJECTION
Approval history
1996-03-01Manufacturing (CMC) · Supplement 30 · standardAP
1995-03-10Manufacturing (CMC) · Supplement 29 · standardAP
1993-08-27Labeling · Supplement 27 · standardAP
1992-02-12Manufacturing (CMC) · Supplement 26 · standardAP
1989-05-16Labeling · Supplement 19 · standardAP
1985-09-30Manufacturing (CMC) · Supplement 21 · standardAP
1984-10-03Manufacturing (CMC) · Supplement 20 · standardAP
1982-03-04Manufacturing (CMC) · Supplement 15 · standardAP
1981-10-16Manufacturing (CMC) · Supplement 16 · standardAP
1979-08-15Labeling · Supplement 13 · standardAP
1951-12-21Type 2 - New Active Ingredient · 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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