Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008228
Company: MERCK

Products on NDA 008228

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCORTONE	HYDROCORTISONE ACETATE	25MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
HYDROCORTONE	HYDROCORTISONE ACETATE	50MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 008228

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/21/1951	ORIG-1	Approval	Type 2 - New Active Ingredient	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
03/01/1996	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
03/10/1995	SUPPL-29	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/27/1993	SUPPL-27	Labeling		Label is not available on this site.
02/12/1992	SUPPL-26	Manufacturing (CMC)-Formulation		Label is not available on this site.
09/30/1985	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
10/03/1984	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
05/16/1989	SUPPL-19	Labeling		Label is not available on this site.
10/16/1981	SUPPL-16	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/04/1982	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
08/15/1979	SUPPL-13	Labeling		Label is not available on this site.