Details for New Drug Application (NDA): 021135

NDA 021135 describes VENOFER, which is a drug marketed by Am Regent and is included in one NDA. It is available from three suppliers. Additional details are available on the VENOFER profile page.

The generic ingredient in VENOFER is ferric oxyhydroxide. There are twenty drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ferric oxyhydroxide profile page.

Summary for 021135

Tradename:	VENOFER
Applicant:	Am Regent
Ingredient:	ferric oxyhydroxide
Patents:	0

Pharmacology for NDA: 021135

Mechanism of Action

Phosphate Chelating Activity

Suppliers and Packaging for NDA: 021135

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VENOFER	ferric oxyhydroxide	INJECTABLE;INTRAVENOUS	021135	NDA	American Regent, Inc.	0517-2310	0517-2310-05	5 VIAL, SINGLE-DOSE in 1 BOX (0517-2310-05) / 10 mL in 1 VIAL, SINGLE-DOSE (0517-2310-01)
VENOFER	ferric oxyhydroxide	INJECTABLE;INTRAVENOUS	021135	NDA	American Regent, Inc.	0517-2325	0517-2325-10	10 VIAL, SINGLE-DOSE in 1 BOX (0517-2325-10) / 2.5 mL in 1 VIAL, SINGLE-DOSE (0517-2325-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 100MG IRON/5ML (EQ 20MG IRON/ML)
Approval Date:	Nov 6, 2000	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)
Approval Date:	Mar 20, 2005	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML)
Approval Date:	Mar 29, 2005	TE:		RLD:	No

Complete Access Available with Subscription