Last Updated: September 24, 2026

Details for New Drug Application (NDA): 021357

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NDA 021357 describes MULTIHANCE, which is a drug marketed by Bracco and is included in two NDAs. It is available from one supplier. Additional details are available on the MULTIHANCE profile page.

The generic ingredient in MULTIHANCE is gadobenate dimeglumine. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the gadobenate dimeglumine profile page.

Summary for 021357

Tradename:	MULTIHANCE
Applicant:	Bracco
Ingredient:	gadobenate dimeglumine
Patents:	0

Pharmacology for NDA: 021357

Mechanism of Action	Magnetic Resonance Contrast Activity

Suppliers and Packaging for NDA: 021357

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MULTIHANCE	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357	NDA	BRACCO DIAGNOSTICS INC	0270-5164	0270-5164-12	5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-12) / 5 mL in 1 VIAL, SINGLE-DOSE
MULTIHANCE	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357	NDA	BRACCO DIAGNOSTICS INC	0270-5164	0270-5164-13	5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-13) / 10 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	2.645GM/5ML (529MG/ML)
Approval Date:	Nov 23, 2004	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	5.29GM/10ML (529MG/ML)
Approval Date:	Nov 23, 2004	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	7.935GM/15ML (529MG/ML)
Approval Date:	Nov 23, 2004	TE:		RLD:	Yes

Expired US Patents for NDA 021357

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	MULTIHANCE	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357-001	Nov 23, 2004	4,916,246	⤷ Start Trial
Bracco	MULTIHANCE	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357-004	Nov 23, 2004	4,916,246	⤷ Start Trial
Bracco	MULTIHANCE	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357-003	Nov 23, 2004	4,916,246	⤷ Start Trial
Bracco	MULTIHANCE	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357-002	Nov 23, 2004	4,916,246	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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