Application 210701

Type: ANDA
Sponsor: APOTEX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMBRISENTAN	AMBRISENTAN	TABLET;ORAL	5MG	No	No
002	AMBRISENTAN	AMBRISENTAN	TABLET;ORAL	10MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60505-4552	Ambrisentan	AMBRISENTAN	Apotex Corp.	ANDA	Current
60505-4552	Ambrisentan	AMBRISENTAN	Apotex Corp.	ANDA	Current
60505-4553	Ambrisentan	AMBRISENTAN	Apotex Corp.	ANDA	Current
60505-4553	Ambrisentan	AMBRISENTAN	Apotex Corp.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76418	ORIG	2023-11-06