Details for New Drug Application (NDA): 022180

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NDA 022180 describes FERAHEME, which is a drug marketed by Covis and is included in one NDA. It is available from one supplier. Additional details are available on the FERAHEME profile page.

The generic ingredient in FERAHEME is ferumoxytol. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the ferumoxytol profile page.

Summary for 022180

Tradename:	FERAHEME
Applicant:	Covis
Ingredient:	ferumoxytol
Patents:	0

Pharmacology for NDA: 022180

Suppliers and Packaging for NDA: 022180

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180	NDA	AMAG Pharmaceuticals, Inc.	59338-775	59338-775-01	1 VIAL, SINGLE-USE in 1 CARTON (59338-775-01) / 17 mL in 1 VIAL, SINGLE-USE
FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180	NDA	AMAG Pharmaceuticals, Inc.	59338-775	59338-775-10	10 VIAL, SINGLE-USE in 1 CARTON (59338-775-10) / 17 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)
Approval Date:	Jun 30, 2009	TE:	AB	RLD:	Yes

Expired US Patents for NDA 022180

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	⤷ Sign Up	⤷ Sign Up
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	⤷ Sign Up	⤷ Sign Up
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	⤷ Sign Up	⤷ Sign Up
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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