Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016721
Company: VALEANT PHARM INTL

• Medication Guide

• Other Important Information from FDA

Products on NDA 16721

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DALMANE	FLURAZEPAM HYDROCHLORIDE	15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	No	No
DALMANE	FLURAZEPAM HYDROCHLORIDE	30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No

Labels for NDA 016721

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/27/2009	SUPPL-77	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016721s077lbl.pdf
10/30/2007	SUPPL-76	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016721s076lbl.pdf