Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021357

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MULTIHANCE (GADOBENATE DIMEGLUMINE)
2.645GM/5ML (529MG/ML) Marketing Status: Prescription

Active Ingredient: GADOBENATE DIMEGLUMINE
Proprietary Name: MULTIHANCE
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 2.645GM/5ML (529MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021357
Product Number: 001
Approval Date: Nov 23, 2004
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MULTIHANCE (GADOBENATE DIMEGLUMINE)
5.29GM/10ML (529MG/ML) Marketing Status: Prescription

Active Ingredient: GADOBENATE DIMEGLUMINE
Proprietary Name: MULTIHANCE
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 5.29GM/10ML (529MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021357
Product Number: 002
Approval Date: Nov 23, 2004
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MULTIHANCE (GADOBENATE DIMEGLUMINE)
7.935GM/15ML (529MG/ML) Marketing Status: Prescription

Active Ingredient: GADOBENATE DIMEGLUMINE
Proprietary Name: MULTIHANCE
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 7.935GM/15ML (529MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021357
Product Number: 003
Approval Date: Nov 23, 2004
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MULTIHANCE (GADOBENATE DIMEGLUMINE)
10.58GM/20ML (529MG/ML) Marketing Status: Prescription

Active Ingredient: GADOBENATE DIMEGLUMINE
Proprietary Name: MULTIHANCE
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 10.58GM/20ML (529MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021357
Product Number: 004
Approval Date: Nov 23, 2004
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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