Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019568
Company: VALEANT PHARMS NORTH

Products on NDA 19568

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DERMATOP	PREDNICARBATE	0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	OINTMENT;TOPICAL	Discontinued	None	Yes	No

Labels for NDA 019568

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/06/2010	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019568s014lbl.pdf
07/02/2004	SUPPL-8	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19568scf008_dermatop_lbl.pdf