Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012376
Company: MERCK

Products on NDA 012376

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DECADRON	DEXAMETHASONE	0.5MG/5ML	ELIXIR;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012376

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/07/1960	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
08/27/1993	SUPPL-28	Labeling		Label is not available on this site.
01/12/1989	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
05/16/1989	SUPPL-22	Labeling		Label is not available on this site.
02/10/1982	SUPPL-19	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/21/1982	SUPPL-18	Labeling		Label is not available on this site.
08/15/1979	SUPPL-17	Labeling		Label is not available on this site.
03/01/1979	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.