APPLICATION
ANDA080701
TYPE
ANDA
ORIGINAL APPROVAL
1972-11-14
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PREDNISONEDiscontinued
PREDNISONE 5MG · TABLET · ORAL
Approval history
1998-12-01Manufacturing (CMC) · Supplement 88AP
1995-04-05Labeling · Supplement 85AP
1995-01-12Manufacturing (CMC) · Supplement 79AP
1994-12-23Manufacturing (CMC) · Supplement 87AP
1994-10-11Manufacturing (CMC) · Supplement 86AP
1994-04-04Labeling · Supplement 84AP
1992-04-03Manufacturing (CMC) · Supplement 83AP
1992-04-03Manufacturing (CMC) · Supplement 81AP
1991-04-05Labeling · Supplement 78AP
1991-04-05Manufacturing (CMC) · Supplement 77AP
1989-03-02Labeling · Supplement 76AP
1986-02-05Manufacturing (CMC) · Supplement 71AP
1972-11-14OriginalAP
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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