Application 018248

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYTOCIN	OXYTOCIN	INJECTABLE;INJECTION	10USP UNITS/ML (10USP UNITS/ML)	Yes	Yes
002	OXYTOCIN	OXYTOCIN	INJECTABLE;INJECTION	100USP UNITS/10ML (10USP UNITS/ML)	Yes	Yes
003	OXYTOCIN	OXYTOCIN	INJECTABLE;INJECTION	300USP UNITS/30ML (10USP UNITS/ML)	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55154-9356	Oxytocin	OXYTOCIN	Cardinal Health	NDA	Current
55154-9577	Oxytocin	OXYTOCIN	Cardinal Health	NDA	Current
55154-9577	Oxytocin	OXYTOCIN	Cardinal Health	NDA	Current
55154-9584	Oxytocin	OXYTOCIN	Cardinal Health	NDA	Current
55154-9584	Oxytocin	OXYTOCIN	Cardinal Health 107, LLC	NDA	Current
63323-012	Oxytocin	OXYTOCIN	Fresenius Kabi USA, LLC	NDA	Current
63323-012	Oxytocin	OXYTOCIN	Fresenius Kabi USA, LLC	NDA	Current
63323-012	Oxytocin	OXYTOCIN	APP Pharmaceuticals, LLC	NDA	Current
63323-012	Oxytocin	OXYTOCIN	Fresenius Kabi USA, LLC	NDA	Current
63323-012	Oxytocin	OXYTOCIN	Fresenius Kabi USA, LLC	NDA	Current
63323-012	Oxytocin	OXYTOCIN	Fresenius Kabi USA, LLC	NDA	Current
63323-012	Oxytocin	OXYTOCIN	Fresenius Kabi USA, LLC	NDA	Current
63323-012	Oxytocin	OXYTOCIN	Fresenius Kabi USA, LLC	NDA	Current
63323-012	Oxytocin	OXYTOCIN	Fresenius Kabi USA, LLC	NDA	Current
63323-012	Oxytocin	OXYTOCIN	Fresenius Kabi USA, LLC	NDA	Current
63323-012	Oxytocin	OXYTOCIN	Fresenius Kabi USA, LLC	NDA	Current