Application 021759

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ELOXATIN	OXALIPLATIN	INJECTABLE;INTRAVENOUS	50MG/10ML (5MG/ML)	Yes	Yes
002	ELOXATIN	OXALIPLATIN	INJECTABLE;INTRAVENOUS	100MG/20ML (5MG/ML)	Yes	Yes
003	ELOXATIN	OXALIPLATIN	INJECTABLE;INTRAVENOUS	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0955-1725	OXALIPLATIN	oxaliplatin	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1725	OXALIPLATIN	oxaliplatin	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1725	OXALIPLATIN	oxaliplatin	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1727	OXALIPLATIN	oxaliplatin	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1727	OXALIPLATIN	oxaliplatin	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1727	OXALIPLATIN	oxaliplatin	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1731	OXALIPLATIN	oxaliplatin	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1731	OXALIPLATIN	oxaliplatin	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1731	OXALIPLATIN	oxaliplatin	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1733	OXALIPLATIN	oxaliplatin	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1733	OXALIPLATIN	oxaliplatin	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1733	OXALIPLATIN	oxaliplatin	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
12516-0592	ELOXATIN	oxaliplatin	Aventis Pharma Ltd.	NDA	Current