Details for New Drug Application (NDA): 021489
✉ Email this page to a colleague
The generic ingredient in PROHANCE MULTIPACK is gadoteridol. One supplier is 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 | ⤷ Sign Up | ⤷ Sign Up |
Bracco | PROHANCE MULTIPACK | gadoteridol | INJECTABLE;INJECTION | 021489-001 | Oct 9, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Bracco | PROHANCE MULTIPACK | gadoteridol | INJECTABLE;INJECTION | 021489-001 | Oct 9, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Bracco | PROHANCE MULTIPACK | gadoteridol | INJECTABLE;INJECTION | 021489-001 | Oct 9, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription