Application 076583

Type: ANDA
Sponsor: SANDOZ INC

Related Records

Company: SANDOZ INC

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	SOLUTION/DROPS;OPHTHALMIC	0.5%	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-2746	KETOROLAC TROMETHAMINE	ketorolac tromethamine	A-S Medication Solutions	ANDA	Current
50090-2746	KETOROLAC TROMETHAMINE	ketorolac tromethamine	A-S Medication Solutions	ANDA	Current
53002-7780	KETOROLAC TROMETHAMINE	ketorolac tromethamine	RPK Pharmaceuticals, Inc.	ANDA	Current
61314-126	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Sandoz Inc	ANDA	Current
61314-126	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Sandoz Inc	ANDA	Current
61314-126	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Sandoz Inc	ANDA	Current
61314-126	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Sandoz Inc	ANDA	Current
68071-2252	KETOROLAC TROMETHAMINE	ketorolac tromethamine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2252	KETOROLAC TROMETHAMINE	ketorolac tromethamine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7517	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7517	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7517	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7517	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Preferred Pharmaceuticals, Inc.	ANDA	Current
71205-296	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Proficient Rx LP	ANDA	Current
71205-296	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Proficient Rx LP	ANDA	Current
71205-296	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Proficient Rx LP	ANDA	Current
71205-296	KETOROLAC TROMETHAMINE	ketorolac tromethamine	Proficient Rx LP	ANDA	Current

Documents

Document	Submission type	Date
8928	ORIG	2009-11-10