Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 019968
Company: SUN PHARM INDS INC

Products on NDA 19968

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ULTRAVATE	HALOBETASOL PROPIONATE	0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	OINTMENT;TOPICAL	Discontinued	None	Yes	No

Labels for NDA 019968

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/02/2012	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019968s011lbl.pdf
09/17/2004	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19968s007lbl.pdf