APPLICATION
ANDA083764
TYPE
ANDA
ORIGINAL APPROVAL
1974-02-13
LATEST ACTION
1999-02-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PREDNISOLONE ACETATEDiscontinued
PREDNISOLONE ACETATE 50MG/ML · INJECTABLE · INJECTION
Approval history
1999-02-19Manufacturing (CMC) · Supplement 195AP
1999-02-02Manufacturing (CMC) · Supplement 194AP
1998-06-08Manufacturing (CMC) · Supplement 193AP
1997-01-24Manufacturing (CMC) · Supplement 192AP
1991-04-15Labeling · Supplement 190AP
1991-01-11Manufacturing (CMC) · Supplement 188AP
1991-01-11Manufacturing (CMC) · Supplement 187AP
1989-11-08Labeling · Supplement 189AP
1988-12-30Bioequivalence · Supplement 182AP
1986-06-16Manufacturing (CMC) · Supplement 181AP
1984-10-31Manufacturing (CMC) · Supplement 180AP
1982-09-17Manufacturing (CMC) · Supplement 179AP
1982-05-19Manufacturing (CMC) · Supplement 178AP
1982-04-05Manufacturing (CMC) · Supplement 177AP
1974-02-13OriginalAP
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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