Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012052
Company: MERCK

Products on NDA 012052

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCORTONE	HYDROCORTISONE SODIUM PHOSPHATE	EQ 50MG BASE/ML	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012052

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/08/1960	ORIG-1	Approval	Type 3 - New Dosage Form	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
12/01/1997	SUPPL-51	Manufacturing (CMC)-Control		Label is not available on this site.
05/02/1997	SUPPL-49	Manufacturing (CMC)-Control		Label is not available on this site.
01/16/1997	SUPPL-48	Manufacturing (CMC)-Control		Label is not available on this site.
03/01/1996	SUPPL-45	Manufacturing (CMC)		Label is not available on this site.
02/29/1996	SUPPL-44	Manufacturing (CMC)-Control		Label is not available on this site.
08/26/1993	SUPPL-42	Labeling		Label is not available on this site.
09/10/1993	SUPPL-41	Manufacturing (CMC)-Control		Label is not available on this site.
09/06/1989	SUPPL-40	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/08/1985	SUPPL-34	Labeling		Label is not available on this site.
02/23/1984	SUPPL-33	Labeling		Label is not available on this site.
01/15/1986	SUPPL-32	Manufacturing (CMC)-Control		Label is not available on this site.
10/16/1981	SUPPL-29	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/04/1982	SUPPL-28	Manufacturing (CMC)-Control		Label is not available on this site.
01/14/1980	SUPPL-27	Labeling		Label is not available on this site.
06/27/1977	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.