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FDA ANDA · ANDA085151

PREDNISONE

Sponsor: PVT FORM

APPLICATION
ANDA085151
TYPE
ANDA
ORIGINAL APPROVAL
1976-08-26
LATEST ACTION
1985-10-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PREDNISONEDiscontinued
PREDNISONE 20MG · TABLET · ORAL

Approval history

1985-10-21Manufacturing (CMC) · Supplement 16AP
1985-10-21Manufacturing (CMC) · Supplement 15AP
1985-10-07Manufacturing (CMC) · Supplement 14AP
1985-10-07Manufacturing (CMC) · Supplement 12AP
1985-10-07Manufacturing (CMC) · Supplement 13AP
1976-08-26OriginalAP
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