Last Updated: September 24, 2026

Details for New Drug Application (NDA): 021489

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NDA 021489 describes PROHANCE 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 PROHANCE MULTIPACK profile page.

The generic ingredient in PROHANCE MULTIPACK is gadoteridol. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the gadoteridol profile page.

Summary for 021489

Tradename:	PROHANCE MULTIPACK
Applicant:	Bracco
Ingredient:	gadoteridol
Patents:	0

Pharmacology for NDA: 021489

Mechanism of Action	Magnetic Resonance Contrast Activity

Suppliers and Packaging for NDA: 021489

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROHANCE MULTIPACK	gadoteridol	INJECTABLE;INJECTION	021489	NDA	Bracco Diagnostics Inc	0270-1111	0270-1111-01	5 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-01) / 10 mL in 1 VIAL, SINGLE-DOSE
PROHANCE MULTIPACK	gadoteridol	INJECTABLE;INJECTION	021489	NDA	Bracco Diagnostics Inc	0270-1111	0270-1111-02	5 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-02) / 15 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	279.3MG/ML
Approval Date:	Oct 9, 2003	TE:		RLD:	Yes

Expired US Patents for NDA 021489

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	PROHANCE MULTIPACK	gadoteridol	INJECTABLE;INJECTION	021489-001	Oct 9, 2003	4,885,363	⤷ Start Trial
Bracco	PROHANCE MULTIPACK	gadoteridol	INJECTABLE;INJECTION	021489-001	Oct 9, 2003	6,143,274	⤷ Start Trial
Bracco	PROHANCE MULTIPACK	gadoteridol	INJECTABLE;INJECTION	021489-001	Oct 9, 2003	5,846,519	⤷ Start Trial
Bracco	PROHANCE MULTIPACK	gadoteridol	INJECTABLE;INJECTION	021489-001	Oct 9, 2003	5,474,756	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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