Application 018057

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PLATINOL	CISPLATIN	INJECTABLE;INJECTION	10MG/VIAL	Yes	No
002	PLATINOL	CISPLATIN	INJECTABLE;INJECTION	50MG/VIAL	Yes	No
003	PLATINOL-AQ	CISPLATIN	INJECTABLE;INJECTION	0.5MG/ML	Yes	No
004	CISPLATIN	CISPLATIN	INJECTABLE;INJECTION	1MG/ML	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
44567-509	CISplatin	CISplatin	WG Critical Care, LLC	NDA	Current
44567-509	CISplatin	CISplatin	WG Critical Care, LLC	NDA	Current
44567-509	CISplatin	CISplatin	WG Critical Care, LLC	NDA	Current
44567-510	CISplatin	CISplatin	WG Critical Care, LLC	NDA	Current
44567-510	CISplatin	CISplatin	WG Critical Care, LLC	NDA	Current
44567-510	CISplatin	CISplatin	WG Critical Care, LLC	NDA	Current
44567-511	CISplatin	CISplatin	WG Critical Care, LLC	NDA	Current
44567-511	CISplatin	CISplatin	WG Critical Care, LLC	NDA	Current
44567-511	CISplatin	CISplatin	WG Critical Care, LLC	NDA	Current
44567-530	Cisplatin	cisplatin	WG Critical Care, LLC	NDA	Current
44567-530	Cisplatin	cisplatin	WG Critical Care, LLC	NDA	Current
44567-530	Cisplatin	cisplatin	WG Critical Care, LLC	NDA	Current
61126-003	Platinol	cisplatin	Corden Pharma Latina S.p.A.	NDA	Current
61126-004	Platinol-AQ	cisplatin	Corden Pharma Latina S.p.A.	NDA	Current