Application 075563

Type: ANDA
Sponsor: OXFORD PHARMS

Related Records

Company: OXFORD PHARMS

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
0603-5769	Sotalol Hydrochloride	Sotalol Hydrochloride	Par Pharmaceutical	ANDA	Current
0603-5770	Sotalol Hydrochloride	Sotalol Hydrochloride	Par Pharmaceutical	ANDA	Current
0603-5771	Sotalol Hydrochloride	Sotalol Hydrochloride	Par Pharmaceutical	ANDA	Current
0603-5772	Sotalol Hydrochloride	Sotalol Hydrochloride	Par Pharmaceutical	ANDA	Current
0615-5552	Sotalol Hydrochloride	Sotalol Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
43353-616	Sotalol Hydrochloride	Sotalol Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
63187-426	Sotalol Hydrochloride	Sotalol Hydrochloride	Proficient Rx LP	ANDA	Current
63187-426	Sotalol Hydrochloride	Sotalol Hydrochloride	Proficient Rx LP	ANDA	Current
63629-2421	Sotalol Hydrochloride	Sotalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2421	Sotalol Hydrochloride	Sotalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2421	Sotalol Hydrochloride	Sotalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2421	Sotalol Hydrochloride	Sotalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2422	Sotalol Hydrochloride	Sotalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2422	Sotalol Hydrochloride	Sotalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2422	Sotalol Hydrochloride	Sotalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2422	Sotalol Hydrochloride	Sotalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2423	Sotalol Hydrochloride	Sotalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2423	Sotalol Hydrochloride	Sotalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2423	Sotalol Hydrochloride	Sotalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2423	Sotalol Hydrochloride	Sotalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-4719	Sotalol Hydrochloride	Sotalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
68071-2014	Sotalol Hydrochloride	Sotalol Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
68151-2702	Sotalol Hydrochloride	Sotalol Hydrochloride	Carilion Materials Management	ANDA	Current
69584-841	Sotalol Hydrochloride	Sotalol Hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-841	Sotalol Hydrochloride	Sotalol Hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-841	Sotalol Hydrochloride	Sotalol Hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-842	Sotalol Hydrochloride	Sotalol Hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-842	Sotalol Hydrochloride	Sotalol Hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-842	Sotalol Hydrochloride	Sotalol Hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-843	Sotalol Hydrochloride	Sotalol Hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-843	Sotalol Hydrochloride	Sotalol Hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-843	Sotalol Hydrochloride	Sotalol Hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-844	Sotalol Hydrochloride	Sotalol Hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-844	Sotalol Hydrochloride	Sotalol Hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-844	Sotalol Hydrochloride	Sotalol Hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
71335-1917	Sotalol Hydrochloride	Sotalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1917	Sotalol Hydrochloride	Sotalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1917	Sotalol Hydrochloride	Sotalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71610-474	Sotalol Hydrochloride	Sotalol Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-474	Sotalol Hydrochloride	Sotalol Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72789-135	Sotalol Hydrochloride	Sotalol Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-135	Sotalol Hydrochloride	Sotalol Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-135	Sotalol Hydrochloride	Sotalol Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-135	Sotalol Hydrochloride	Sotalol Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-136	Sotalol Hydrochloride	Sotalol Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-136	Sotalol Hydrochloride	Sotalol Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-136	Sotalol Hydrochloride	Sotalol Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-136	Sotalol Hydrochloride	Sotalol Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-137	Sotalol Hydrochloride	Sotalol Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-137	Sotalol Hydrochloride	Sotalol Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-137	Sotalol Hydrochloride	Sotalol Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-137	Sotalol Hydrochloride	Sotalol Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-138	Sotalol Hydrochloride	Sotalol Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-138	Sotalol Hydrochloride	Sotalol Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-138	Sotalol Hydrochloride	Sotalol Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-138	Sotalol Hydrochloride	Sotalol Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current