Details for New Drug Application (NDA): 021489
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The generic ingredient in PROHANCE MULTIPACK is gadoteridol. Two suppliers are listed for this compound. Additional details are available on the gadoteridol profile page.
Summary for 021489
| Tradename: | PROHANCE MULTIPACK |
| Applicant: | Bracco |
| Ingredient: | gadoteridol |
| Patents: | 0 |
Pharmacology for NDA: 021489
| Mechanism of Action | Magnetic Resonance Contrast Activity |
Suppliers and Packaging for NDA: 021489
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROHANCE MULTIPACK | gadoteridol | INJECTABLE;INJECTION | 021489 | NDA | Bracco Diagnostics Inc | 0270-1111 | 0270-1111-01 | 5 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-01) / 10 mL in 1 VIAL, SINGLE-DOSE |
| PROHANCE MULTIPACK | gadoteridol | INJECTABLE;INJECTION | 021489 | NDA | Bracco Diagnostics Inc | 0270-1111 | 0270-1111-02 | 5 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-02) / 15 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 279.3MG/ML | ||||
| Approval Date: | Oct 9, 2003 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 021489
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bracco | PROHANCE MULTIPACK | gadoteridol | INJECTABLE;INJECTION | 021489-001 | Oct 9, 2003 | ⤷ Get Started Free | ⤷ Get Started Free |
| Bracco | PROHANCE MULTIPACK | gadoteridol | INJECTABLE;INJECTION | 021489-001 | Oct 9, 2003 | ⤷ Get Started Free | ⤷ Get Started Free |
| Bracco | PROHANCE MULTIPACK | gadoteridol | INJECTABLE;INJECTION | 021489-001 | Oct 9, 2003 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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