Last Updated: September 24, 2026

Details for New Drug Application (NDA): 020131

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NDA 020131 describes PROHANCE, 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 PROHANCE profile page.

The generic ingredient in PROHANCE 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 020131

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

Pharmacology for NDA: 020131

Mechanism of Action	Magnetic Resonance Contrast Activity

Suppliers and Packaging for NDA: 020131

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROHANCE	gadoteridol	INJECTABLE;INJECTION	020131	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	gadoteridol	INJECTABLE;INJECTION	020131	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:	Nov 16, 1992	TE:	AP	RLD:	Yes

Expired US Patents for NDA 020131

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	PROHANCE	gadoteridol	INJECTABLE;INJECTION	020131-001	Nov 16, 1992	⤷ Start Trial	⤷ Start Trial
Bracco	PROHANCE	gadoteridol	INJECTABLE;INJECTION	020131-001	Nov 16, 1992	⤷ Start Trial	⤷ Start Trial
Bracco	PROHANCE	gadoteridol	INJECTABLE;INJECTION	020131-001	Nov 16, 1992	⤷ Start Trial	⤷ Start Trial
Bracco	PROHANCE	gadoteridol	INJECTABLE;INJECTION	020131-001	Nov 16, 1992	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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