Application 020862

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HECTOROL	DOXERCALCIFEROL	CAPSULE;ORAL	2.5MCG	Yes	Yes
002	HECTOROL	DOXERCALCIFEROL	CAPSULE;ORAL	0.5MCG	Yes	No
003	HECTOROL	DOXERCALCIFEROL	CAPSULE;ORAL	1MCG	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0955-1720	Doxercalciferol	Doxercalciferol	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1720	Doxercalciferol	Doxercalciferol	Winthrop U.S.	NDA	Current
0955-1720	Doxercalciferol	Doxercalciferol	Winthrop U.S, a business of sanofi-aventis U.S. LLC	NDA AUTHORIZED GENERIC	Current
0955-1720	Doxercalciferol	Doxercalciferol	Winthrop U.S.	NDA	Current
0955-1720	Doxercalciferol	Doxercalciferol	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1721	Doxercalciferol	Doxercalciferol	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1721	Doxercalciferol	Doxercalciferol	Winthrop U.S.	NDA	Current
0955-1721	Doxercalciferol	Doxercalciferol	Winthrop U.S, a business of sanofi-aventis U.S. LLC	NDA AUTHORIZED GENERIC	Current
0955-1721	Doxercalciferol	Doxercalciferol	Winthrop U.S.	NDA	Current
0955-1721	Doxercalciferol	Doxercalciferol	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1722	Doxercalciferol	Doxercalciferol	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1722	Doxercalciferol	Doxercalciferol	Winthrop U.S.	NDA	Current
0955-1722	Doxercalciferol	Doxercalciferol	Winthrop U.S, a business of sanofi-aventis U.S. LLC	NDA AUTHORIZED GENERIC	Current
0955-1722	Doxercalciferol	Doxercalciferol	Winthrop U.S.	NDA	Current
0955-1722	Doxercalciferol	Doxercalciferol	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current