Application 209449

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NITYR	NITISINONE	TABLET;ORAL	2MG	Yes	No
002	NITYR	NITISINONE	TABLET;ORAL	5MG	Yes	No
003	NITYR	NITISINONE	TABLET;ORAL	10MG	Yes	Yes
004	HARLIKU	NITISINONE	TABLET;ORAL	2MG	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70709-000	NITYR	Nitisinone	Cycle Pharmaceuticals Ltd.	NDA	Current
70709-000	NITYR	Nitisinone	Cycle Pharmaceuticals Ltd.	NDA	Current
70709-000	NITYR	Nitisinone	Cycle Pharmaceuticals Ltd.	NDA	Current
70709-000	NITYR	Nitisinone	Cycle Pharmaceuticals Ltd.	NDA	Current
70709-000	NITYR	Nitisinone	Cycle Pharmaceuticals Ltd.	NDA	Current
70709-000	NITYR	Nitisinone	Cycle Pharmaceuticals Ltd.	NDA	Current
70709-000	NITYR	Nitisinone	Cycle Pharmaceuticals Ltd.	NDA	Current
70709-002	NITYR	Nitisinone	Cycle Pharmaceuticals Ltd.	NDA	Current
70709-002	NITYR	Nitisinone	Cycle Pharmaceuticals Ltd.	NDA	Current
70709-002	NITYR	Nitisinone	Cycle Pharmaceuticals Ltd.	NDA	Current
70709-002	NITYR	Nitisinone	Cycle Pharmaceuticals Ltd.	NDA	Current
70709-002	NITYR	Nitisinone	Cycle Pharmaceuticals Ltd.	NDA	Current
70709-002	NITYR	Nitisinone	Cycle Pharmaceuticals Ltd.	NDA	Current
70709-002	NITYR	Nitisinone	Cycle Pharmaceuticals Ltd.	NDA	Current
70709-005	NITYR	Nitisinone	Cycle Pharmaceuticals Ltd.	NDA	Current
70709-005	NITYR	Nitisinone	Cycle Pharmaceuticals Ltd.	NDA	Current
70709-005	NITYR	Nitisinone	Cycle Pharmaceuticals Ltd.	NDA	Current
70709-005	NITYR	Nitisinone	Cycle Pharmaceuticals Ltd.	NDA	Current
70709-005	NITYR	Nitisinone	Cycle Pharmaceuticals Ltd.	NDA	Current
70709-005	NITYR	Nitisinone	Cycle Pharmaceuticals Ltd.	NDA	Current
70709-005	NITYR	Nitisinone	Cycle Pharmaceuticals Ltd.	NDA	Current