Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009986
Company: PHARMACIA AND UPJOHN

Products on NDA 009986

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DELTASONE	PREDNISONE	5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
DELTASONE	PREDNISONE	2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
DELTASONE	PREDNISONE	10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
DELTASONE	PREDNISONE	20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
DELTASONE	PREDNISONE	50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 009986

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.