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Generated: June 27, 2017

DrugPatentWatch Database Preview

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 NDA: 019596

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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

Summary for product number 001

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

Expired Orange Book Patents for NDA: 019596

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
MAGNEVIST
gadopentetate dimeglumine
INJECTABLE;INJECTION019596-001Jun 2, 19885,362,475► Subscribe
Bayer Hlthcare
MAGNEVIST
gadopentetate dimeglumine
INJECTABLE;INJECTION019596-001Jun 2, 19884,647,447► Subscribe
Bayer Hlthcare
MAGNEVIST
gadopentetate dimeglumine
INJECTABLE;INJECTION019596-001Jun 2, 19884,963,344► Subscribe
Bayer Hlthcare
MAGNEVIST
gadopentetate dimeglumine
INJECTABLE;INJECTION019596-001Jun 2, 19885,560,903► Subscribe
Bayer Hlthcare
MAGNEVIST
gadopentetate dimeglumine
INJECTABLE;INJECTION019596-001Jun 2, 19884,957,939► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Moodys
Deloitte
Argus Health
Novartis
US Army
Fish and Richardson
Johnson and Johnson
Chubb
Citi
Healthtrust

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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