TEVA PHARMS USA Application 091589

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOBRAMYCIN	TOBRAMYCIN	SOLUTION;INHALATION	300MG/5ML	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-4085	Tobramycin	Tobramycin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4085	Tobramycin	Tobramycin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4085	Tobramycin	Tobramycin	Teva Pharmaceuticals USA, Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
39618	ORIG	2013-11-20
31541	ORIG	2013-10-11