APPLICATION
ANDA083128
TYPE
ANDA
ORIGINAL APPROVAL
1979-02-27
LATEST ACTION
1999-02-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HYDROCORTISONE ACETATEDiscontinued
HYDROCORTISONE ACETATE 25MG/ML · INJECTABLE · INJECTION
Approval history
1999-02-19Manufacturing (CMC) · Supplement 68AP
1999-02-02Manufacturing (CMC) · Supplement 67AP
1998-06-09Manufacturing (CMC) · Supplement 66AP
1997-06-16Manufacturing (CMC) · Supplement 65AP
1996-09-03Manufacturing (CMC) · Supplement 64AP
1994-11-30Labeling · Supplement 63AP
1994-02-24Labeling · Supplement 62AP
1993-01-26Bioequivalence · Supplement 60AP
1992-10-29Manufacturing (CMC) · Supplement 61AP
1992-07-30Manufacturing (CMC) · Supplement 54AP
1992-05-22Labeling · Supplement 58AP
1991-04-01Labeling · Supplement 59AP
1991-02-11Manufacturing (CMC) · Supplement 55AP
1991-02-11Manufacturing (CMC) · Supplement 56AP
1989-11-15Labeling · Supplement 57AP
1988-12-23Manufacturing (CMC) · Supplement 53AP
1988-12-23Manufacturing (CMC) · Supplement 51AP
1988-12-23Manufacturing (CMC) · Supplement 52AP
1988-12-23Manufacturing (CMC) · Supplement 50AP
1986-06-16Manufacturing (CMC) · Supplement 47AP
1983-05-27Manufacturing (CMC) · Supplement 43AP
1982-06-30Manufacturing (CMC) · Supplement 41AP
1979-02-27OriginalAP
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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