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
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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