APPLICATION
ANDA086595
TYPE
ANDA
ORIGINAL APPROVAL
1979-04-10
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PREDNISONEDiscontinued
PREDNISONE 10MG · TABLET · ORAL
Approval history
1998-12-01Manufacturing (CMC) · Supplement 35AP
1995-04-05Labeling · Supplement 32AP
1994-12-23Manufacturing (CMC) · Supplement 34AP
1994-12-12Labeling · Supplement 27AP
1994-12-12Manufacturing (CMC) · Supplement 25AP
1994-12-12Manufacturing (CMC) · Supplement 26AP
1994-12-12Manufacturing (CMC) · Supplement 24AP
1994-10-11Manufacturing (CMC) · Supplement 33AP
1992-04-03Manufacturing (CMC) · Supplement 29AP
1991-02-19Labeling · Supplement 28AP
1987-04-01Manufacturing (CMC) · Supplement 22AP
1986-01-17Manufacturing (CMC) · Supplement 17AP
1986-01-17Manufacturing (CMC) · Supplement 15AP
1986-01-17Manufacturing (CMC) · Supplement 16AP
1979-04-10OriginalAP
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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