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Details for New Drug Application (NDA): 021037

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NDA 021037 describes MAGNEVIST, which is a drug marketed by Bayer Hlthcare and is included in two NDAs. It is available from two suppliers. Additional details are available on the MAGNEVIST profile page.

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

Summary for NDA: 021037

Tradename:
MAGNEVIST
Applicant:
Bayer Hlthcare
Ingredient:
gadopentetate dimeglumine
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 021037

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MAGNEVIST
gadopentetate dimeglumine
INJECTABLE;INJECTION 021037 NDA AUTHORIZED GENERIC Alvogen, Inc 47781-147 47781-147-20 20 CARTON in 1 BOX (47781-147-20) > 1 VIAL, SINGLE-DOSE in 1 CARTON > 5 mL in 1 VIAL, SINGLE-DOSE
MAGNEVIST
gadopentetate dimeglumine
INJECTABLE;INJECTION 021037 NDA AUTHORIZED GENERIC Alvogen, Inc 47781-147 47781-147-22 20 CARTON in 1 BOX (47781-147-22) > 1 VIAL, SINGLE-DOSE in 1 CARTON > 10 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength469.01MG/ML
Approval Date:Mar 10, 2000TE:RLD:Yes

Expired Orange Book Patents for NDA: 021037

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
MAGNEVIST
gadopentetate dimeglumine
INJECTABLE;INJECTION021037-001Mar 10, 20004,647,447► subscribe
Bayer Hlthcare
MAGNEVIST
gadopentetate dimeglumine
INJECTABLE;INJECTION021037-001Mar 10, 20005,560,903► subscribe
Bayer Hlthcare
MAGNEVIST
gadopentetate dimeglumine
INJECTABLE;INJECTION021037-001Mar 10, 20005,362,475► subscribe
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