Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 009986
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DELTASONE PREDNISONE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
DELTASONE PREDNISONE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
DELTASONE PREDNISONE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
DELTASONE PREDNISONE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
DELTASONE PREDNISONE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/21/1955 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/13/2009 SUPPL-60 Labeling

Label is not available on this site.

03/13/2009 SUPPL-59 Labeling

Label is not available on this site.

03/13/2009 SUPPL-58 Labeling

Label is not available on this site.

03/13/2009 SUPPL-57 Labeling

Label is not available on this site.

05/24/1993 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

12/28/1993 SUPPL-55 Labeling

Label is not available on this site.

03/13/2009 SUPPL-54 Labeling

Label is not available on this site.

04/06/1989 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

03/13/2009 SUPPL-51 Labeling

Label is not available on this site.

03/13/2009 SUPPL-50 Labeling

Label is not available on this site.

05/20/1985 SUPPL-49 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/09/1985 SUPPL-48 Labeling

Label is not available on this site.

03/13/2009 SUPPL-47 Labeling

Label is not available on this site.

07/23/1979 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

04/25/1979 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

01/17/1979 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/1978 SUPPL-42 Labeling

Label is not available on this site.

07/20/1977 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/2009 SUPPL-40 Labeling

Label is not available on this site.

03/13/2009 SUPPL-35 Labeling

Label is not available on this site.

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