Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 009766
Company: SCHERING

Products on NDA 009766

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METICORTEN	PREDNISONE	5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
METICORTEN	PREDNISONE	1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No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 009766

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/21/1955	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/26/1997	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
11/12/2002	SUPPL-15	Labeling		Label is not available on this site.
04/13/1994	SUPPL-14	Labeling		Label is not available on this site.
09/07/1993	SUPPL-13	Labeling		Label is not available on this site.
12/17/1992	SUPPL-12	Labeling		Label is not available on this site.
07/06/1992	SUPPL-11	Labeling		Label is not available on this site.
04/02/1987	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
11/12/2002	SUPPL-9	Labeling		Label is not available on this site.
11/12/2002	SUPPL-8	Labeling		Label is not available on this site.
08/27/1980	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
02/26/1979	SUPPL-6			Label is not available on this site.
01/25/1978	SUPPL-5	Labeling		Label is not available on this site.