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FDA ANDA · ANDA085813

PREDNISONE

Sponsor: RISING

APPLICATION
ANDA085813
TYPE
ANDA
ORIGINAL APPROVAL
1978-05-31
LATEST ACTION
1995-04-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PREDNISONEDiscontinued
PREDNISONE 20MG · TABLET · ORAL

Approval history

1995-04-10Manufacturing (CMC) · Supplement 30AP
1991-02-05Manufacturing (CMC) · Supplement 29AP
1989-08-03Labeling · Supplement 28AP
1987-08-12Manufacturing (CMC) · Supplement 27AP
1987-02-11Manufacturing (CMC) · Supplement 26AP
1986-08-01Manufacturing (CMC) · Supplement 23AP
1986-08-01Manufacturing (CMC) · Supplement 21AP
1986-08-01Manufacturing (CMC) · Supplement 24AP
1986-08-01Manufacturing (CMC) · Supplement 22AP
1986-01-16Manufacturing (CMC) · Supplement 19AP
1986-01-16Manufacturing (CMC) · Supplement 18AP
1986-01-16Manufacturing (CMC) · Supplement 20AP
1985-02-27Manufacturing (CMC) · Supplement 13AP
1984-09-21Manufacturing (CMC) · Supplement 11AP
1984-09-21Manufacturing (CMC) · Supplement 12AP
1982-11-16Manufacturing (CMC) · Supplement 10AP
1982-06-18Manufacturing (CMC) · Supplement 9AP
1982-06-18Manufacturing (CMC) · Supplement 3AP
1982-06-18Manufacturing (CMC) · Supplement 8AP
1982-06-18Manufacturing (CMC) · Supplement 2AP
1978-05-31OriginalAP
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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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