Application 079110

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BICALUTAMIDEBICALUTAMIDETABLET;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-485bicalutamidebicalutamideSun Pharmaceutical Industries, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18493ORIG2009-07-24
31412ORIG2009-07-09