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FDA ANDA · ANDA083398

PREDNISOLONE ACETATE

Sponsor: WATSON LABS

APPLICATION
ANDA083398
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 25MG/ML · INJECTABLE · INJECTION

Approval history

1999-02-19Manufacturing (CMC) · Supplement 143AP
1999-02-02Manufacturing (CMC) · Supplement 142AP
1998-05-27Manufacturing (CMC) · Supplement 141AP
1997-08-06Manufacturing (CMC) · Supplement 140AP
1991-05-09Labeling · Supplement 138AP
1991-01-11Manufacturing (CMC) · Supplement 136AP
1991-01-11Manufacturing (CMC) · Supplement 135AP
1989-10-26Labeling · Supplement 137AP
1988-12-30Bioequivalence · Supplement 131AP
1988-12-23Manufacturing (CMC) · Supplement 133AP
1988-12-23Manufacturing (CMC) · Supplement 134AP
1986-06-16Manufacturing (CMC) · Supplement 130AP
1984-10-31Manufacturing (CMC) · Supplement 129AP
1984-06-27Manufacturing (CMC) · Supplement 125AP
1984-06-27Manufacturing (CMC) · Supplement 83AP
1984-06-27Manufacturing (CMC) · Supplement 126AP
1974-02-13OriginalAP
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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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