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Last Updated: August 17, 2022

Details for New Drug Application (NDA): 201277


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NDA 201277 describes GADAVIST, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the GADAVIST profile page.

The generic ingredient in GADAVIST is gadobutrol. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the gadobutrol profile page.
Summary for 201277
Tradename:GADAVIST
Applicant:Bayer Hlthcare
Ingredient:gadobutrol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201277
Suppliers and Packaging for NDA: 201277
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-325 50419-325-18 2 CARTON in 1 BOX (50419-325-18) > 5 BOTTLE, GLASS in 1 CARTON > 30 mL in 1 BOTTLE, GLASS
GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-325 50419-325-19 10 BOTTLE, GLASS in 1 BOX (50419-325-19) > 65 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength4.5354GM/7.5ML (604.72MG/ML)
Approval Date:Mar 14, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 12, 2022
Regulatory Exclusivity Use:USE IN CARDIAC MRI TO ASSESS MYOCARDIAL PERFUSION (STRESS, REST) AND LATE GADOLINIUM ENHANCEMENT IN ADULT PATIENTS WITH KNOWN OR SUSPECTED CORONARY ARTERY DISEASE (CAD)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength6.0472GM/10ML (604.72MG/ML)
Approval Date:Mar 14, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 12, 2022
Regulatory Exclusivity Use:USE IN CARDIAC MRI TO ASSESS MYOCARDIAL PERFUSION (STRESS, REST) AND LATE GADOLINIUM ENHANCEMENT IN ADULT PATIENTS WITH KNOWN OR SUSPECTED CORONARY ARTERY DISEASE (CAD)

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength9.0708GM/15ML (604.72MG/ML)
Approval Date:Mar 14, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 12, 2022
Regulatory Exclusivity Use:USE IN CARDIAC MRI TO ASSESS MYOCARDIAL PERFUSION (STRESS, REST) AND LATE GADOLINIUM ENHANCEMENT IN ADULT PATIENTS WITH KNOWN OR SUSPECTED CORONARY ARTERY DISEASE (CAD)

Expired US Patents for NDA 201277

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-005 Mar 14, 2011 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-006 Dec 18, 2013 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-002 Mar 14, 2011 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare GADAVIST gadobutrol SOLUTION;INTRAVENOUS 201277-001 Mar 14, 2011 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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