FDA.reportPublic FDA data

Application 021412

Type
NDA
Sponsor
BIOVAIL LABS INTL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOVALT ODTZOLPIDEM TARTRATETABLET, ORALLY DISINTEGRATING;ORAL5MGNoNo
002TOVALT ODTZOLPIDEM TARTRATETABLET, ORALLY DISINTEGRATING;ORAL10MGNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42143ORIG2009-04-14
36861ORIG2007-05-01
5305ORIG2007-05-01
27718ORIG2005-05-27