APPLICATION
ANDA087773
TYPE
ANDA
ORIGINAL APPROVAL
1982-07-13
LATEST ACTION
1998-02-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PREDNISONEDiscontinued
PREDNISONE 10MG · TABLET · ORAL
Approval history
1998-02-03Manufacturing (CMC) · Supplement 19AP
1998-02-03Manufacturing (CMC) · Supplement 21AP
1998-02-03Manufacturing (CMC) · Supplement 20AP
1994-11-02Labeling · Supplement 18AP
1993-12-23Labeling · Supplement 17AP
1991-02-05Labeling · Supplement 16AP
1988-09-30Manufacturing (CMC) · Supplement 13AP
1988-04-06Manufacturing (CMC) · Supplement 11AP
1988-04-06Manufacturing (CMC) · Supplement 12AP
1988-04-06Manufacturing (CMC) · Supplement 10AP
1986-12-11Manufacturing (CMC) · Supplement 7AP
1986-09-05Manufacturing (CMC) · Supplement 8AP
1982-07-13OriginalAP
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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