PHARMACYCLICS INC Application 217003

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IMBRUVICA	IBRUTINIB	SUSPENSION;ORAL	70MG/ML	No	No
002	IMBRUVICA	IBRUTINIB	CAPSULE;ORAL	70MG	No	No
003	IMBRUVICA	IBRUTINIB	CAPSULE;ORAL	140MG	No	No
004	IMBRUVICA	IBRUTINIB	TABLET;ORAL	140MG	No	No
005	IMBRUVICA	IBRUTINIB	TABLET;ORAL	230MG	No	No
006	IMBRUVICA	IBRUTINIB	TABLET;ORAL	420MG	No	No
007	IMBRUVICA	IBRUTINIB	TABLET;ORAL	560MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57962-007	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current
57962-007	Imbruvica	Ibrutinib	Pharmacyclics LLC	NDA	Current