Details for New Drug Application (NDA): 217480

NDA 217480 describes GADOBUTROL, which is a drug marketed by Hainan Poly Pharm and Hengrui Pharma and is included in two NDAs. It is available from two suppliers. Additional details are available on the GADOBUTROL profile page.

The generic ingredient in GADOBUTROL 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 217480

Tradename:	GADOBUTROL
Applicant:	Hainan Poly Pharm
Ingredient:	gadobutrol
Patents:	0

Pharmacology for NDA: 217480

Mechanism of Action

Magnetic Resonance Contrast Activity

Suppliers and Packaging for NDA: 217480

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GADOBUTROL	gadobutrol	SOLUTION;INTRAVENOUS	217480	ANDA	Slate Run Pharmaceuticals, LLC	70436-212	70436-212-54	20 VIAL, SINGLE-DOSE in 1 CARTON (70436-212-54) / 7.5 mL in 1 VIAL, SINGLE-DOSE (70436-212-32)
GADOBUTROL	gadobutrol	SOLUTION;INTRAVENOUS	217480	ANDA	Slate Run Pharmaceuticals, LLC	70436-212	70436-212-80	1 VIAL, SINGLE-DOSE in 1 CARTON (70436-212-80) / 7.5 mL in 1 VIAL, SINGLE-DOSE (70436-212-32)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	4.5354GM/7.5ML (604.72MG/ML)
Approval Date:	Mar 15, 2023	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	9.0708GM/15ML (604.72MG/ML)
Approval Date:	Mar 15, 2023	TE:	AP	RLD:	No

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