Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008917
Company: PHARMACIA AND UPJOHN

Products on NDA 008917

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CORTEF ACETATE	HYDROCORTISONE ACETATE	2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	OINTMENT;TOPICAL	Discontinued	None	Yes	No
CORTEF ACETATE	HYDROCORTISONE ACETATE	1%	OINTMENT;TOPICAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 008917

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/28/1953	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
07/05/1990	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
04/28/1987	SUPPL-19	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/28/1987	SUPPL-18	Manufacturing (CMC)-Formulation		Label is not available on this site.
10/14/1982	SUPPL-17	Labeling		Label is not available on this site.
03/19/1980	SUPPL-16	Labeling		Label is not available on this site.
10/11/1977	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
02/10/1977	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
10/12/1976	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
06/03/1976	SUPPL-11	Labeling		Label is not available on this site.