Details for New Drug Application (NDA): 020976
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The generic ingredient in OPTIMARK IN PLASTIC CONTAINER is gadoversetamide. There is one drug master file entry for this compound. Additional details are available on the gadoversetamide profile page.
Summary for 020976
Tradename: | OPTIMARK IN PLASTIC CONTAINER |
Applicant: | Liebel-flarsheim |
Ingredient: | gadoversetamide |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 9927MG/30ML (330.9MG/ML) | ||||
Approval Date: | Dec 8, 1999 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 3309MG/10ML (330.9MG/ML) | ||||
Approval Date: | Dec 8, 1999 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 4963.5MG/15ML (330.9MG/ML) | ||||
Approval Date: | Dec 8, 1999 | TE: | RLD: | Yes |
Expired US Patents for NDA 020976
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Liebel-flarsheim | OPTIMARK IN PLASTIC CONTAINER | gadoversetamide | INJECTABLE;INJECTION | 020976-001 | Dec 8, 1999 | 5,130,120 | ⤷ Subscribe |
Liebel-flarsheim | OPTIMARK IN PLASTIC CONTAINER | gadoversetamide | INJECTABLE;INJECTION | 020976-001 | Dec 8, 1999 | 5,137,711 | ⤷ Subscribe |
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