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Generated: November 13, 2018

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Details for New Drug Application (NDA): 019596

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NDA 019596 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 019596
Tradename:MAGNEVIST
Applicant:Bayer Hlthcare
Ingredient:gadopentetate dimeglumine
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 019596
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MAGNEVIST gadopentetate dimeglumine INJECTABLE;INJECTION 019596 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 019596 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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength469.01MG/ML
Approval Date:Jun 2, 1988TE:RLD:Yes

Expired US Patents for NDA 019596

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare MAGNEVIST gadopentetate dimeglumine INJECTABLE;INJECTION 019596-001 Jun 2, 1988 ➤ Try a Free Trial ➤ Try a Free Trial
Bayer Hlthcare MAGNEVIST gadopentetate dimeglumine INJECTABLE;INJECTION 019596-001 Jun 2, 1988 ➤ Try a Free Trial ➤ Try a Free Trial
Bayer Hlthcare MAGNEVIST gadopentetate dimeglumine INJECTABLE;INJECTION 019596-001 Jun 2, 1988 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Queensland Health
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Moodys
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