SYNTHON PHARMS Application 077973

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BICALUTAMIDE	BICALUTAMIDE	TABLET;ORAL	50MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63672-0005	Bicalutamide	Bicalutamide	Synthon Pharmaceuticals, Inc.	ANDA	Current
67253-191	bicalutamide	bicalutamide	Dava Pharmaceuticals, Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
18470	ORIG	2009-07-24
31313	ORIG	2009-07-09