APPLICATION
NDA009986
TYPE
NDA
ORIGINAL APPROVAL
1955-06-21
LATEST ACTION
2009-03-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DELTASONE · ReferenceDiscontinued
PREDNISONE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
DELTASONE · ReferenceDiscontinued
PREDNISONE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
DELTASONE · ReferenceDiscontinued
PREDNISONE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
DELTASONE · ReferenceDiscontinued
PREDNISONE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
DELTASONE · ReferenceDiscontinued
PREDNISONE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2009-03-13Labeling · Supplement 54AP
2009-03-13Labeling · Supplement 60 · standardAP
2009-03-13Labeling · Supplement 50AP
2009-03-13Labeling · Supplement 40AP
2009-03-13Labeling · Supplement 59 · standardAP
2009-03-13Labeling · Supplement 57 · standardAP
2009-03-13Labeling · Supplement 47AP
2009-03-13Labeling · Supplement 51AP
2009-03-13Labeling · Supplement 35AP
2009-03-13Labeling · Supplement 58 · standardAP
1993-12-28Labeling · Supplement 55AP
1993-05-24Manufacturing (CMC) · Supplement 56 · standardAP
1989-04-06Manufacturing (CMC) · Supplement 52 · standardAP
1985-05-20Manufacturing (CMC) · Supplement 49 · standardAP
1985-01-09Labeling · Supplement 48AP
1979-07-23Manufacturing (CMC) · Supplement 45 · standardAP
1979-04-25Manufacturing (CMC) · Supplement 44 · standardAP
1979-01-17Manufacturing (CMC) · Supplement 43 · standardAP
1978-10-18Labeling · Supplement 42AP
1977-07-20Manufacturing (CMC) · Supplement 41 · standardAP
1955-06-21Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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