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Generated: April 26, 2019

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Details for New Drug Application (NDA): 021358

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NDA 021358 describes MULTIHANCE 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 MULTIHANCE MULTIPACK profile page.

The generic ingredient in MULTIHANCE MULTIPACK is gadobenate dimeglumine. One supplier is listed for this compound. Additional details are available on the gadobenate dimeglumine profile page.
Summary for 021358
Tradename:MULTIHANCE MULTIPACK
Applicant:Bracco
Ingredient:gadobenate dimeglumine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021358
Suppliers and Packaging for NDA: 021358
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MULTIHANCE MULTIPACK gadobenate dimeglumine INJECTABLE;INTRAVENOUS 021358 NDA BRACCO DIAGNOSTICS INC 0270-5264 0270-5264-16 5 BOTTLE, GLASS in 1 BOX (0270-5264-16) > 50 mL in 1 BOTTLE, GLASS
MULTIHANCE MULTIPACK gadobenate dimeglumine INJECTABLE;INTRAVENOUS 021358 NDA BRACCO DIAGNOSTICS INC 0270-5264 0270-5264-17 5 BOTTLE, GLASS in 1 BOX (0270-5264-17) > 100 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength26.45GM/50ML (529MG/ML)
Approval Date:Nov 23, 2004TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength52.9GM/100ML (529MG/ML)
Approval Date:Nov 23, 2004TE:RLD:Yes

Expired US Patents for NDA 021358

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bracco MULTIHANCE MULTIPACK gadobenate dimeglumine INJECTABLE;INTRAVENOUS 021358-001 Nov 23, 2004 ➤ Sign Up ➤ Sign Up
Bracco MULTIHANCE MULTIPACK gadobenate dimeglumine INJECTABLE;INTRAVENOUS 021358-002 Nov 23, 2004 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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