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FDA ANDA · ANDA085085

PREDNISOLONE

Sponsor: WATSON LABS

APPLICATION
ANDA085085
TYPE
ANDA
ORIGINAL APPROVAL
1976-06-29
LATEST ACTION
1994-04-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PREDNISOLONEDiscontinued
PREDNISOLONE 5MG · TABLET · ORAL

Approval history

1994-04-06Labeling · Supplement 25AP
1994-01-06Labeling · Supplement 24AP
1988-03-03Labeling · Supplement 23AP
1987-12-01Manufacturing (CMC) · Supplement 22AP
1987-10-15Manufacturing (CMC) · Supplement 18AP
1987-10-15Manufacturing (CMC) · Supplement 20AP
1987-10-15Manufacturing (CMC) · Supplement 19AP
1987-10-15Manufacturing (CMC) · Supplement 17AP
1986-12-23Manufacturing (CMC) · Supplement 16AP
1986-02-14Manufacturing (CMC) · Supplement 15AP
1984-03-19Labeling · Supplement 14AP
1983-03-29Manufacturing (CMC) · Supplement 8AP
1982-10-04Manufacturing (CMC) · Supplement 9AP
1976-06-29OriginalAP
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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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