APPLICATION
ANDA089983
TYPE
ANDA
ORIGINAL APPROVAL
1989-01-12
LATEST ACTION
2001-05-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PREDNISONEDiscontinued
PREDNISONE 10MG · TABLET · ORAL
Approval history
2001-05-09Manufacturing (CMC) · Supplement 5AP
1994-01-24Manufacturing (CMC) · Supplement 4AP
1992-10-15Manufacturing (CMC) · Supplement 3AP
1989-08-03Labeling · Supplement 1AP
1989-01-12OriginalAP
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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