Application 213498

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PONVORY	PONESIMOD	TABLET;ORAL	2MG	Yes	No
002	PONVORY	PONESIMOD	TABLET;ORAL	3MG	Yes	No
003	PONVORY	PONESIMOD	TABLET;ORAL	4MG	Yes	No
004	PONVORY	PONESIMOD	TABLET;ORAL	5MG	Yes	No
005	PONVORY	PONESIMOD	TABLET;ORAL	6MG	Yes	No
006	PONVORY	PONESIMOD	TABLET;ORAL	7MG	Yes	No
007	PONVORY	PONESIMOD	TABLET;ORAL	8MG	Yes	No
008	PONVORY	PONESIMOD	TABLET;ORAL	9MG	Yes	No
009	PONVORY	PONESIMOD	TABLET;ORAL	10MG	Yes	No
010	PONVORY	PONESIMOD	TABLET;ORAL	20MG	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50458-707	PONVORY	Ponesimod	Janssen Pharmaceuticals, Inc	NDA	Current
50458-707	PONVORY	Ponesimod	Janssen Pharmaceuticals, Inc	NDA	Current
50458-707	PONVORY	Ponesimod	Janssen Pharmaceuticals, Inc	NDA	Current
50458-707	PONVORY	Ponesimod	Janssen Pharmaceuticals, Inc	NDA	Current
50458-720	PONVORY	Ponesimod	Janssen Pharmaceuticals, Inc	NDA	Current
50458-720	PONVORY	Ponesimod	Janssen Pharmaceuticals, Inc	NDA	Current
50458-720	PONVORY	Ponesimod	Janssen Pharmaceuticals, Inc	NDA	Current
50458-720	PONVORY	Ponesimod	Janssen Pharmaceuticals, Inc	NDA	Current