Application 075429

Type: ANDA
Sponsor: TEVA

Related Records

Company: TEVA

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	TABLET;ORAL	80MG	No	No
002	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	TABLET;ORAL	120MG	No	No
003	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	TABLET;ORAL	160MG	No	No
004	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	TABLET;ORAL	240MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-1060	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1060	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1060	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1060	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1061	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1061	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1061	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1061	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1062	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1062	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1062	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1062	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1063	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1063	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1063	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1063	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
71205-046	Sotalol Hydrochloride	Sotalol Hydrochloride	Proficient Rx LP	ANDA	Current
71205-046	Sotalol Hydrochloride	Sotalol Hydrochloride	Proficient Rx LP	ANDA	Current
71205-046	Sotalol Hydrochloride	Sotalol Hydrochloride	Proficient Rx LP	ANDA	Current
71335-0860	Sotalol Hydrochloride	Sotalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0860	Sotalol Hydrochloride	Sotalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0860	Sotalol Hydrochloride	Sotalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current

Documents

Document	Submission type	Submission no.	Date
30880	ORIG	1	2004-06-17
18410	ORIG	1	2004-06-17
42995	ORIG	1	2001-12-17
30881	ORIG	1	2000-05-01