Application 075133

Type: ANDA
Sponsor: WATSON LABS

Related Records

Company: WATSON LABS

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	TABLET;ORAL	100MG	No	No
002	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	TABLET;ORAL	200MG	No	No
003	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	TABLET;ORAL	300MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-0605	Labetalol hydrochloride	Labetalol hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-0606	Labetalol hydrochloride	Labetalol hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-0607	Labetalol hydrochloride	Labetalol hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0904-5928	Labetalol hydrochloride	Labetalol hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-5928	Labetalol hydrochloride	Labetalol hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-5928	Labetalol hydrochloride	Labetalol hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-5929	Labetalol hydrochloride	Labetalol hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-5929	Labetalol hydrochloride	Labetalol hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-5929	Labetalol hydrochloride	Labetalol hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-5930	Labetalol hydrochloride	Labetalol hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-5930	Labetalol hydrochloride	Labetalol hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-5930	Labetalol hydrochloride	Labetalol hydrochloride	Major Pharmaceuticals	ANDA	Current
21695-592	Labetalol hydrochloride	Labetalol hydrochloride	Rebel Distributors Corp	ANDA	Current
21695-988	Labetalol hydrochloride	Labetalol hydrochloride	Rebel Distributors Corp	ANDA	Current
21695-994	Labetalol hydrochloride	Labetalol hydrochloride	Rebel Distributors Corp	ANDA	Current
50436-4364	Labetalol hydrochloride	Labetalol hydrochloride	Unit Dose Services	ANDA	Current
55154-5876	Labetalol hydrochloride	Labetalol hydrochloride	Cardinal Health	ANDA	Current
55154-5876	Labetalol hydrochloride	Labetalol hydrochloride	Cardinal Health	ANDA	Current
55154-6877	Labetalol hydrochloride	Labetalol hydrochloride	Cardinal Health	ANDA	Current
55154-6877	Labetalol hydrochloride	Labetalol hydrochloride	Cardinal Health	ANDA	Current
60429-277	Labetalol hydrochloride	Labetalol hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-278	Labetalol hydrochloride	Labetalol hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-279	Labetalol hydrochloride	Labetalol hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60760-291	Labetalol hydrochloride	Labetalol hydrochloride	St Marys Medical Park Pharmacy	ANDA	Current
63629-5268	Labetalol hydrochloride	Labetalol hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-5268	Labetalol hydrochloride	Labetalol hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-5311	Labetalol hydrochloride	Labetalol hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-5311	Labetalol hydrochloride	Labetalol hydrochloride	Bryant Ranch Prepack	ANDA	Current
71205-095	Labetalol hydrochloride	Labetalol hydrochloride	Proficient Rx LP	ANDA	Current
71205-095	Labetalol hydrochloride	Labetalol hydrochloride	Proficient Rx LP	ANDA	Current
71205-095	Labetalol hydrochloride	Labetalol hydrochloride	Proficient Rx LP	ANDA	Current

Documents

Document	Submission type	Date
42939	ORIG	2002-09-25
8531	ORIG	1998-08-03