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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021358

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MULTIHANCE MULTIPACK (GADOBENATE DIMEGLUMINE)
26.45GM/50ML (529MG/ML)
Marketing Status: Prescription
Active Ingredient: GADOBENATE DIMEGLUMINE
Proprietary Name: MULTIHANCE MULTIPACK
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 26.45GM/50ML (529MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021358
Product Number: 001
Approval Date: Nov 23, 2004
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
MULTIHANCE MULTIPACK (GADOBENATE DIMEGLUMINE)
52.9GM/100ML (529MG/ML)
Marketing Status: Prescription
Active Ingredient: GADOBENATE DIMEGLUMINE
Proprietary Name: MULTIHANCE MULTIPACK
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 52.9GM/100ML (529MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021358
Product Number: 002
Approval Date: Nov 23, 2004
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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