Application 017441

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INFED	IRON DEXTRAN	INJECTABLE;INJECTION	EQ 50MG IRON/ML	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-6082	INFeD	Iron Dextran	Allergan, Inc.	NDA	Current
0023-6082	INFeD	Iron Dextran	Allergan, Inc.	NDA	Current
0023-6082	INFeD	Iron Dextran	Allergan, Inc.	NDA	Current
0023-6082	INFeD	Iron Dextran	Allergan, Inc.	NDA	Current
0023-6082	INFeD	Iron Dextran	Allergan, Inc.	NDA	Current
0023-6082	INFeD	Iron Dextran	Allergan, Inc.	NDA	Current
0023-6082	INFeD	Iron Dextran	Allergan, Inc.	NDA	Current
0023-6082	INFeD	Iron Dextran	Allergan, Inc.	NDA	Current
0404-9879	INFED	iron dextran	Henry Schein, Inc.	NDA	Current
0404-9879	INFED	iron dextran	Henry Schein, Inc.	NDA	Current
0404-9879	INFED	iron dextran	Henry Schein, Inc.	NDA	Current
51662-1441	IRON DEXTRAN	IRON DEXTRAN	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1441	IRON DEXTRAN	IRON DEXTRAN	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
52544-931	INFeD	Iron Dextran	Actavis Pharma, Inc.	NDA	Current
52544-931	INFeD	Iron Dextran	Actavis Pharma, Inc.	NDA	Current
52584-086	INFED	iron dextran	General Injectables & Vaccines, Inc.	NDA	Current
52584-086	INFED	iron dextran	General Injectables & Vaccines, Inc.	NDA	Current
52584-086	INFED	iron dextran	General Injectables & Vaccines, Inc.	NDA	Current
52584-086	INFED	iron dextran	General Injectables & Vaccines, Inc.	NDA	Current
52584-086	INFED	iron dextran	General Injectables & Vaccines, Inc.	NDA	Current
52584-931	Infed	Iron Dextran	General Injectables & Vaccines, Inc	NDA	Current
52584-931	Infed	Iron Dextran	General Injectables & Vaccines, Inc	NDA	Current
52584-931	Infed	Iron Dextran	General Injectables & Vaccines, Inc	NDA	Current