HOSPIRA Application 013025

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	THAM-E	POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE	INJECTABLE;INJECTION	370MG/VIAL;1.75GM/VIAL;36GM/VIAL	No	No
002	THAM	TROMETHAMINE	INJECTABLE;INJECTION	3.6GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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
0409-1593	THAM	TROMETHAMINE	Hospira, Inc.	NDA	Current

Document, Submission type, Date table
Document	Submission type	Date
350	SUPPL	2006-07-21
33099	SUPPL	2006-07-20