Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016675
Company: MERCK

Products on NDA 016675

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DECADRON-LA	DEXAMETHASONE ACETATE	EQ 8MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016675

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/06/1973	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-32	Manufacturing (CMC)		Label is not available on this site.
08/27/1993	SUPPL-28	Labeling		Label is not available on this site.
12/11/1989	SUPPL-27	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/08/1985	SUPPL-20	Labeling		Label is not available on this site.
05/16/1989	SUPPL-19	Labeling		Label is not available on this site.
02/21/1983	SUPPL-18	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/04/1982	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
12/21/1981	SUPPL-15	Manufacturing (CMC)-Formulation		Label is not available on this site.
12/03/1981	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
08/08/1979	SUPPL-12	Labeling		Label is not available on this site.