CURIUM Application 213792

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IOFLUPANE I-123	IOFLUPANE I-123	SOLUTION;INTRAVENOUS	5mCi/2.5ML (2mCi/ML)	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69945-166	Ioflupane I 123	IOFLUPANE I-123	Curium US LLC	ANDA	Current
69945-166	Ioflupane I 123	IOFLUPANE I-123	Curium US LLC	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
71704	ORIG	2022-08-03