Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012515
Company: DELCOR ASSET CORP

Products on NDA 012515

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KENACORT	TRIAMCINOLONE DIACETATE	EQ 4MG BASE/5ML	SYRUP;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012515

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/21/1961	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	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
09/07/1993	SUPPL-21	Labeling		Label is not available on this site.
06/30/1982	SUPPL-19	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/13/2009	SUPPL-18	Labeling		Label is not available on this site.
08/21/1979	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
03/13/2009	SUPPL-16	Labeling		Label is not available on this site.
07/17/1979	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
11/02/1978	SUPPL-12	Labeling		Label is not available on this site.
03/13/2009	SUPPL-10	Labeling		Label is not available on this site.