Application 076139

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	TABLET;ORAL	10MG	No	No
002	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	TABLET;ORAL	20MG	No	No
003	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	TABLET;ORAL	40MG	No	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7222	Fosinopril Sodium	Fosinopril Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7222	Fosinopril Sodium	Fosinopril Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7223	Fosinopril Sodium	Fosinopril Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7223	Fosinopril Sodium	Fosinopril Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7224	Fosinopril Sodium	Fosinopril Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7224	Fosinopril Sodium	Fosinopril Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
71335-0873	Fosinopril Sodium	Fosinopril Sodium	Bryant Ranch Prepack	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
82678	ORIG	2025-06-27