Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 013334
Company: MERCK

Products on NDA 013334

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DECADRON W/ XYLOCAINE	DEXAMETHASONE SODIUM PHOSPHATE; LIDOCAINE HYDROCHLORIDE	EQ 4MG PHOSPHATE/ML;10MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 013334

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/11/1962	ORIG-1	Approval	Type 4 - New Combination	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-34	Manufacturing (CMC)		Label is not available on this site.
08/27/1993	SUPPL-32	Labeling		Label is not available on this site.
02/12/1991	SUPPL-30	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/08/1985	SUPPL-23	Labeling		Label is not available on this site.
02/21/1983	SUPPL-21	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/04/1982	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
05/21/1982	SUPPL-18	Labeling		Label is not available on this site.
07/13/1979	SUPPL-17	Labeling		Label is not available on this site.