Details for New Drug Application (NDA): 021358
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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
Mechanism of Action | Magnetic Resonance Contrast Activity |
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: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 26.45GM/50ML (529MG/ML) | ||||
Approval Date: | Nov 23, 2004 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 52.9GM/100ML (529MG/ML) | ||||
Approval Date: | Nov 23, 2004 | TE: | 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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