Application 020617

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PYTEST	UREA, C-14	CAPSULE;ORAL	1uCi	Yes	Yes
002	PYTEST KIT	UREA, C-14	CAPSULE;ORAL	1uCi	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42536-6044	PYtest	Urea, C-14	Avent, Inc.	NDA	Current
42536-6044	PYtest	Urea, C-14	Avent, Inc.	NDA	Current
42536-6044	PYtest	Urea, C-14	Avent, Inc.	NDA	Current
42536-6044	PYtest	Urea, C-14	Avent, Inc.	NDA	Current
42536-6046	PYtest	Urea, C-14	Avent, Inc.	NDA	Current
42536-6046	PYtest	Urea, C-14	Avent, Inc.	NDA	Current
42536-6046	PYtest	Urea, C-14	Avent, Inc.	NDA	Current
42536-6046	PYtest	Urea, C-14	Avent, Inc.	NDA	Current