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Generated: November 18, 2018

DrugPatentWatch Database Preview

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. One supplier is 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021489
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 0270-1111-70 5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0270-1111-70) > 50 mL in 1 VIAL, PHARMACY BULK 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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength279.3MG/ML
Approval Date:Oct 9, 2003TE:RLD:Yes

Expired US Patents for NDA 021489

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bracco PROHANCE MULTIPACK gadoteridol INJECTABLE;INJECTION 021489-001 Oct 9, 2003 ➤ Sign Up ➤ Sign Up
Bracco PROHANCE MULTIPACK gadoteridol INJECTABLE;INJECTION 021489-001 Oct 9, 2003 ➤ Sign Up ➤ Sign Up
Bracco PROHANCE MULTIPACK gadoteridol INJECTABLE;INJECTION 021489-001 Oct 9, 2003 ➤ Sign Up ➤ Sign Up
Bracco PROHANCE MULTIPACK gadoteridol INJECTABLE;INJECTION 021489-001 Oct 9, 2003 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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