Details for New Drug Application (NDA): 020123
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The generic ingredient in OMNISCAN is gadodiamide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the gadodiamide profile page.
Summary for 020123
Tradename: | OMNISCAN |
Applicant: | Ge Healthcare |
Ingredient: | gadodiamide |
Patents: | 0 |
Pharmacology for NDA: 020123
Mechanism of Action | Magnetic Resonance Contrast Activity |
Suppliers and Packaging for NDA: 020123
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OMNISCAN | gadodiamide | INJECTABLE;INJECTION | 020123 | NDA | GE Healthcare Inc. | 0407-0690 | 0407-0690-05 | 10 VIAL in 1 BOX (0407-0690-05) / 5 mL in 1 VIAL |
OMNISCAN | gadodiamide | INJECTABLE;INJECTION | 020123 | NDA | GE Healthcare Inc. | 0407-0690 | 0407-0690-10 | 10 VIAL in 1 BOX (0407-0690-10) / 10 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 287MG/ML | ||||
Approval Date: | Jan 8, 1993 | TE: | RLD: | Yes |
Expired US Patents for NDA 020123
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ge Healthcare | OMNISCAN | gadodiamide | INJECTABLE;INJECTION | 020123-001 | Jan 8, 1993 | 4,687,659 | ⤷ Subscribe |
Ge Healthcare | OMNISCAN | gadodiamide | INJECTABLE;INJECTION | 020123-001 | Jan 8, 1993 | 5,362,475 | ⤷ Subscribe |
Ge Healthcare | OMNISCAN | gadodiamide | INJECTABLE;INJECTION | 020123-001 | Jan 8, 1993 | 5,560,903 | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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