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. Three suppliers are 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

Pharmacology for NDA: 201277

Mechanism of Action	Magnetic Resonance Contrast Activity

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:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	4.5354GM/7.5ML (604.72MG/ML)
Approval Date:	Mar 14, 2011	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	6.0472GM/10ML (604.72MG/ML)
Approval Date:	Mar 14, 2011	TE:	AP	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	9.0708GM/15ML (604.72MG/ML)
Approval Date:	Mar 14, 2011	TE:	AP	RLD:	Yes

Expired US Patents for NDA 201277

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-004	Mar 14, 2011	5,980,864	⤷ Subscribe
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-006	Dec 18, 2013	5,980,864	⤷ Subscribe
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-005	Mar 14, 2011	5,980,864	⤷ Subscribe
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-003	Mar 14, 2011	5,980,864	⤷ Subscribe
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-002	Mar 14, 2011	5,980,864	⤷ Subscribe
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-001	Mar 14, 2011	5,980,864	⤷ Subscribe
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