APPLICATION
NDA009766
TYPE
NDA
ORIGINAL APPROVAL
1955-02-21
LATEST ACTION
2002-11-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METICORTEN · ReferenceDiscontinued
PREDNISONE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
METICORTEN · ReferenceDiscontinued
PREDNISONE 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2002-11-12Labeling · Supplement 15 · standardAP
2002-11-12Labeling · Supplement 8AP
2002-11-12Labeling · Supplement 9AP
1997-08-26Manufacturing (CMC) · Supplement 16 · priorityAP
1994-04-13Labeling · Supplement 14 · standardAP
1993-09-07Labeling · Supplement 13 · standardAP
1992-12-17Labeling · Supplement 12AP
1992-07-06Labeling · Supplement 11AP
1987-04-02Manufacturing (CMC) · Supplement 10 · priorityAP
1980-08-27Manufacturing (CMC) · Supplement 7 · priorityAP
1979-02-26Supplement · Supplement 6 · priorityAP
1978-01-25Labeling · Supplement 5AP
1955-02-21Type 1 - New Molecular Entity · Original · priorityAP
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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