Application 213736

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PEMAZYRE	PEMIGATINIB	TABLET;ORAL	4.5MG	Yes	No
002	PEMAZYRE	PEMIGATINIB	TABLET;ORAL	9MG	Yes	No
003	PEMAZYRE	PEMIGATINIB	TABLET;ORAL	13.5MG	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50881-026	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-026	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-026	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-026	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-026	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-027	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-027	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-027	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-027	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-027	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-028	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-028	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-028	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-028	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current
50881-028	PEMAZYRE	pemigatinib	Incyte Corporation	NDA	Current