GLAND PHARMA LTD Application 076722

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	INJECTABLE;INJECTION	15MG/ML	No	No
002	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	INJECTABLE;INJECTION	30MG/ML	No	No
003	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	INJECTABLE; INJECTION	60MG/2ML	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68083-103	Ketorolac Tromethamine	Ketorolac Tromethamine	Gland Pharma Limited	ANDA	Current
68083-104	Ketorolac Tromethamine	Ketorolac Tromethamine	Gland Pharma Limited	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
43100	ORIG	2007-07-06