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Last Updated: March 29, 2024

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. One supplier is listed for this compound. Additional details are available on the gadoteridol profile page.
Summary for 020131
Tradename:PROHANCE
Applicant:Bracco
Ingredient:gadoteridol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020131
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 0270-1111-70 5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0270-1111-70) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
PROHANCE gadoteridol INJECTABLE;INJECTION 020131 NDA BRACCO DIAGNOSTICS INC 0270-1111 0270-1111-85 5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0270-1111-85) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength279.3MG/ML
Approval Date:Nov 16, 1992TE:RLD:Yes

Expired US Patents for NDA 020131

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

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