SUN PHARM Application 078818

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXALIPLATIN	OXALIPLATIN	INJECTABLE;INTRAVENOUS	50MG/VIAL	No	No
002	OXALIPLATIN	OXALIPLATIN	INJECTABLE;INTRAVENOUS	100MG/VIAL	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47335-176	Oxaliplatin	Oxaliplatin	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-178	Oxaliplatin	Oxaliplatin	Sun Pharmaceutical Industries, Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
39565	SUPPL	2013-03-22
31390	SUPPL	2013-03-22