Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 021358

Expand all

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English