LUPIN Application 211531

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DAPAGLIFLOZIN	DAPAGLIFLOZIN	TABLET;ORAL	5MG	No	No
002	DAPAGLIFLOZIN	DAPAGLIFLOZIN	TABLET;ORAL	10MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70748-105	Dapagliflozin	Dapagliflozin	Lupin Pharmaceuticals, Inc.	ANDA	Current
70748-106	Dapagliflozin	Dapagliflozin	Lupin Pharmaceuticals, Inc.	ANDA	Current