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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. There is one patent protecting this drug. 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 NDA: 201277

Tradename:
GADAVIST
Applicant:
Bayer Hlthcare
Ingredient:
gadobutrol
Patents:1
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 50419-325-11 2 CARTON in 1 BOX (50419-325-11) > 10 VIAL, SINGLE-DOSE in 1 CARTON > 7.5 mL in 1 VIAL, SINGLE-DOSE
GADAVIST
gadobutrol
SOLUTION;INTRAVENOUS 201277 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-325 50419-325-12 2 CARTON in 1 BOX (50419-325-12) > 10 VIAL, SINGLE-DOSE in 1 CARTON > 10 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength4.5354GM/7.5ML (604.72MG/ML)
Approval Date:Mar 14, 2011TE:RLD:Yes
Patent:5,980,864Patent Expiration:Nov 9, 2016Product Flag?YSubstance Flag?YDelist Request?
Patented Use:CONTRAST AGENT FOR MAGNETIC RESONANCE IMAGING
Regulatory Exclusivity Expiration:Jun 11, 2017
Regulatory Exclusivity Use:GADAVIST IS INDICATED WITH MRI TO DETECT THE PRESENCE AND EXTENT OF MALIGNANT BREAST DISEASE
Regulatory Exclusivity Expiration:Mar 14, 2016
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

Expired Orange Book Patents for NDA: 201277

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
GADAVIST
gadobutrol
SOLUTION;INTRAVENOUS201277-004Mar 14, 20115,980,864► subscribe
Bayer Hlthcare
GADAVIST
gadobutrol
SOLUTION;INTRAVENOUS201277-001Mar 14, 20115,980,864► subscribe
Bayer Hlthcare
GADAVIST
gadobutrol
SOLUTION;INTRAVENOUS201277-005Mar 14, 20115,980,864► subscribe
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