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FDA ANDA · ANDA085884

CORTISONE ACETATE

Sponsor: WATSON LABS

APPLICATION
ANDA085884
TYPE
ANDA
ORIGINAL APPROVAL
1978-05-15
LATEST ACTION
1999-03-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CORTISONE ACETATEDiscontinued
CORTISONE ACETATE 25MG · TABLET · ORAL

Approval history

1999-03-18Manufacturing (CMC) · Supplement 29AP
1999-03-18Manufacturing (CMC) · Supplement 27AP
1999-03-18Manufacturing (CMC) · Supplement 28AP
1999-03-18Manufacturing (CMC) · Supplement 30AP
1997-04-24Manufacturing (CMC) · Supplement 26AP
1994-07-13Labeling · Supplement 25AP
1994-04-11Manufacturing (CMC) · Supplement 19AP
1994-04-11Manufacturing (CMC) · Supplement 18AP
1994-04-11Manufacturing (CMC) · Supplement 20AP
1994-03-10Labeling · Supplement 24AP
1990-12-04Labeling · Supplement 23AP
1989-12-05Labeling · Supplement 22AP
1989-08-31Labeling · Supplement 21AP
1986-09-04Manufacturing (CMC) · Supplement 16AP
1986-03-11Manufacturing (CMC) · Supplement 15AP
1983-09-26Manufacturing (CMC) · Supplement 11AP
1983-09-26Manufacturing (CMC) · Supplement 10AP
1983-01-18Manufacturing (CMC) · Supplement 7AP
1978-05-15OriginalAP
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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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