Last Updated: September 24, 2026

Details for New Drug Application (NDA): 021358

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NDA 021358 describes MULTIHANCE MULTIPACK, which is a drug marketed by Bracco and is included in one NDA. It is available from one supplier. Additional details are available on the MULTIHANCE MULTIPACK profile page.

The generic ingredient in MULTIHANCE MULTIPACK 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 021358

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

Pharmacology for NDA: 021358

Mechanism of Action	Magnetic Resonance Contrast Activity

Suppliers and Packaging for NDA: 021358

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MULTIHANCE MULTIPACK	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021358	NDA	BRACCO DIAGNOSTICS INC	0270-5264	0270-5264-16	5 BOTTLE, GLASS in 1 BOX (0270-5264-16) / 50 mL in 1 BOTTLE, GLASS
MULTIHANCE MULTIPACK	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021358	NDA	BRACCO DIAGNOSTICS INC	0270-5264	0270-5264-17	5 BOTTLE, GLASS in 1 BOX (0270-5264-17) / 100 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	26.45GM/50ML (529MG/ML)
Approval Date:	Nov 23, 2004	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	52.9GM/100ML (529MG/ML)
Approval Date:	Nov 23, 2004	TE:		RLD:	Yes

Expired US Patents for NDA 021358

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	MULTIHANCE MULTIPACK	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021358-001	Nov 23, 2004	⤷ Start Trial	⤷ Start Trial
Bracco	MULTIHANCE MULTIPACK	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021358-002	Nov 23, 2004	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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