Application 019865

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BETAPACE	SOTALOL HYDROCHLORIDE	TABLET;ORAL	80MG	Yes	No
002	BETAPACE	SOTALOL HYDROCHLORIDE	TABLET;ORAL	160MG	Yes	Yes
003	BETAPACE	SOTALOL HYDROCHLORIDE	TABLET;ORAL	240MG	Yes	No
004	BETAPACE	SOTALOL HYDROCHLORIDE	TABLET;ORAL	320MG	No	No
005	BETAPACE	SOTALOL HYDROCHLORIDE	TABLET;ORAL	120MG	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13672-051	Betapace	sotalol HCl	Skyepharma Production SAS	NDA	Current
13672-051	Betapace	sotalol HCl	Skyepharma Production SAS	NDA	Current
13672-051	Betapace	sotalol HCl	SkyePharma Production SAS	NDA	Current
13672-052	Betapace	sotalol HCl	SkyePharma Production SAS	NDA	Current
13672-052	Betapace	sotalol HCl	Skyepharma Production SAS	NDA	Current
13672-052	Betapace	sotalol HCl	Skyepharma Production SAS	NDA	Current
13672-053	Betapace	sotalol HCl	SkyePharma Production SAS	NDA	Current
13672-053	Betapace	sotalol HCl	Skyepharma Production SAS	NDA	Current
13672-053	Betapace	sotalol HCl	Skyepharma Production SAS	NDA	Current
70515-105	BETAPACE	sotalol hydrochloride	Covis Pharma US, Inc	NDA	Current
70515-105	BETAPACE	sotalol hydrochloride	Covis Pharma	NDA	Current
70515-105	BETAPACE	sotalol hydrochloride	Covis Pharma	NDA	Current
70515-106	BETAPACE	sotalol hydrochloride	Covis Pharma US, Inc	NDA	Current
70515-106	BETAPACE	sotalol hydrochloride	Covis Pharma	NDA	Current
70515-106	BETAPACE	sotalol hydrochloride	Covis Pharma	NDA	Current
70515-109	BETAPACE	sotalol hydrochloride	Covis Pharma US, Inc	NDA	Current
70515-109	BETAPACE	sotalol hydrochloride	Covis Pharma	NDA	Current
70515-109	BETAPACE	sotalol hydrochloride	Covis Pharma	NDA	Current