APPLICATION
ANDA084913
TYPE
ANDA
ORIGINAL APPROVAL
1978-07-17
LATEST ACTION
1987-01-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PREDNISONEDiscontinued
PREDNISONE 2.5MG · TABLET · ORAL
PREDNISONEDiscontinued
PREDNISONE 20MG · TABLET · ORAL
Approval history
1987-01-07Manufacturing (CMC) · Supplement 8AP
1987-01-07Manufacturing (CMC) · Supplement 7AP
1986-05-14Manufacturing (CMC) · Supplement 6AP
1986-05-14Manufacturing (CMC) · Supplement 4AP
1978-07-17OriginalAP
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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