Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021357

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NDA 021357 describes MULTIHANCE, 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 MULTIHANCE profile page.

The generic ingredient in MULTIHANCE is gadobenate dimeglumine. One supplier is listed for this compound. Additional details are available on the gadobenate dimeglumine profile page.
Summary for 021357
Tradename:MULTIHANCE
Applicant:Bracco
Ingredient:gadobenate dimeglumine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021357
Suppliers and Packaging for NDA: 021357
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MULTIHANCE gadobenate dimeglumine INJECTABLE;INTRAVENOUS 021357 NDA BRACCO DIAGNOSTICS INC 0270-5164 0270-5164-12 5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-12) > 5 mL in 1 VIAL, SINGLE-DOSE
MULTIHANCE gadobenate dimeglumine INJECTABLE;INTRAVENOUS 021357 NDA BRACCO DIAGNOSTICS INC 0270-5164 0270-5164-13 5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-13) > 10 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength2.645GM/5ML (529MG/ML)
Approval Date:Nov 23, 2004TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength5.29GM/10ML (529MG/ML)
Approval Date:Nov 23, 2004TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength7.935GM/15ML (529MG/ML)
Approval Date:Nov 23, 2004TE:RLD:Yes

Expired US Patents for NDA 021357

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bracco MULTIHANCE gadobenate dimeglumine INJECTABLE;INTRAVENOUS 021357-001 Nov 23, 2004   Start Trial   Start Trial
Bracco MULTIHANCE gadobenate dimeglumine INJECTABLE;INTRAVENOUS 021357-004 Nov 23, 2004   Start Trial   Start Trial
Bracco MULTIHANCE gadobenate dimeglumine INJECTABLE;INTRAVENOUS 021357-003 Nov 23, 2004   Start Trial   Start Trial
Bracco MULTIHANCE gadobenate dimeglumine INJECTABLE;INTRAVENOUS 021357-002 Nov 23, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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