TEVA PHARMS Application 078717

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	INJECTABLE;INJECTION	50MG/5ML (10MG/ML)	No	No
002	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE	INJECTABLE;INJECTION	100MG/10ML (10MG/ML)	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0703-2394	Rocuronium Bromide	Rocuronium Bromide	Teva Parenteral Medicines	ANDA	Current
0703-2395	Rocuronium Bromide	Rocuronium Bromide	Teva Parenteral Medicines	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
39564	ORIG	2009-01-16
31383	ORIG	2008-12-02