Details for New Drug Application (NDA): 021357
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The generic ingredient in MULTIHANCE is gadobenate dimeglumine. One supplier is listed for this compound. Additional details are available on the gadobenate dimeglumine profile page.
Summary for 021357
Tradename: | MULTIHANCE |
Applicant: | Bracco |
Ingredient: | gadobenate dimeglumine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021357
Mechanism of Action | Magnetic Resonance Contrast Activity |
Suppliers and Packaging for NDA: 021357
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MULTIHANCE | gadobenate dimeglumine | INJECTABLE;INTRAVENOUS | 021357 | NDA | BRACCO DIAGNOSTICS INC | 0270-5164 | 0270-5164-12 | 5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-12) / 5 mL in 1 VIAL, SINGLE-DOSE |
MULTIHANCE | gadobenate dimeglumine | INJECTABLE;INTRAVENOUS | 021357 | NDA | BRACCO DIAGNOSTICS INC | 0270-5164 | 0270-5164-13 | 5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-13) / 10 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 2.645GM/5ML (529MG/ML) | ||||
Approval Date: | Nov 23, 2004 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 5.29GM/10ML (529MG/ML) | ||||
Approval Date: | Nov 23, 2004 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 7.935GM/15ML (529MG/ML) | ||||
Approval Date: | Nov 23, 2004 | TE: | RLD: | Yes |
Expired US Patents for NDA 021357
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bracco | MULTIHANCE | gadobenate dimeglumine | INJECTABLE;INTRAVENOUS | 021357-001 | Nov 23, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Bracco | MULTIHANCE | gadobenate dimeglumine | INJECTABLE;INTRAVENOUS | 021357-003 | Nov 23, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Bracco | MULTIHANCE | gadobenate dimeglumine | INJECTABLE;INTRAVENOUS | 021357-002 | Nov 23, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Bracco | MULTIHANCE | gadobenate dimeglumine | INJECTABLE;INTRAVENOUS | 021357-004 | Nov 23, 2004 | ⤷ Sign Up | ⤷ Sign Up |
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