Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012104
Company: SUN PHARM INDS INC

Products on NDA 12104

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KENALOG	TRIAMCINOLONE ACETONIDE	0.147MG/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SPRAY;TOPICAL	Discontinued	None	Yes	No

Labels for NDA 012104

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/01/2011	SUPPL-32	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012104s032lbl.pdf