Application 205739

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VELTASSA	PATIROMER SORBITEX CALCIUM	POWDER;ORAL	EQ 8.4GM BASE/PACKET	Yes	No
002	VELTASSA	PATIROMER SORBITEX CALCIUM	POWDER;ORAL	EQ 16.8GM BASE/PACKET	Yes	No
003	VELTASSA	PATIROMER SORBITEX CALCIUM	POWDER;ORAL	EQ 25.2GM BASE/PACKET	Yes	Yes
004	VELTASSA	PATIROMER SORBITEX CALCIUM	POWDER;ORAL	EQ 1GM BASE/PACKET	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
53436-084	VELTASSA	patiromer	Vifor Pharma, Inc.	NDA	Current
53436-084	VELTASSA	patiromer	Relypsa, Inc.	NDA	Current
53436-084	VELTASSA	patiromer	Vifor Pharma, Inc.	NDA	Current
53436-084	VELTASSA	patiromer	Relypsa, Inc.	NDA	Current
53436-084	VELTASSA	patiromer	Relypsa, Inc.	NDA	Current
53436-084	VELTASSA	patiromer	Vifor Pharma, Inc.	NDA	Current
53436-084	VELTASSA	patiromer	Vifor Pharma, Inc.	NDA	Current
53436-168	VELTASSA	patiromer	Vifor Pharma, Inc.	NDA	Current
53436-168	VELTASSA	patiromer	Vifor Pharma, Inc.	NDA	Current
53436-168	VELTASSA	patiromer	Relypsa, Inc.	NDA	Current
53436-168	VELTASSA	patiromer	Relypsa, Inc.	NDA	Current
53436-168	VELTASSA	patiromer	Relypsa, Inc.	NDA	Current
53436-168	VELTASSA	patiromer	Vifor Pharma, Inc.	NDA	Current
53436-168	VELTASSA	patiromer	Vifor Pharma, Inc.	NDA	Current
53436-252	VELTASSA	patiromer	Vifor Pharma, Inc.	NDA	Current
53436-252	VELTASSA	patiromer	Vifor Pharma, Inc.	NDA	Current
53436-252	VELTASSA	patiromer	Relypsa, Inc.	NDA	Current
53436-252	VELTASSA	patiromer	Vifor Pharma, Inc.	NDA	Current
53436-252	VELTASSA	patiromer	Relypsa, Inc.	NDA	Current
53436-252	VELTASSA	patiromer	Relypsa, Inc.	NDA	Current
53436-252	VELTASSA	patiromer	Vifor Pharma, Inc.	NDA	Current