Details for New Drug Application (NDA): 209176
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The generic ingredient in RADICAVA is edaravone. Six suppliers are listed for this compound. Additional details are available on the edaravone profile page.
Summary for 209176
| Tradename: | RADICAVA |
| Applicant: | Mitsubishi Tanabe |
| Ingredient: | edaravone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209176
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RADICAVA | edaravone | SOLUTION;INTRAVENOUS | 209176 | NDA | Mitsubishi Tanabe Pharma America, Inc. | 70510-2171 | 70510-2171-2 | 2 BAG in 1 CARTON (70510-2171-2) / 100 mL in 1 BAG (70510-2171-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 30MG/100ML (0.3MG/ML) | ||||
| Approval Date: | May 5, 2017 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 60MG/100ML (0.6MG/ML) | ||||
| Approval Date: | Nov 15, 2018 | TE: | AP | RLD: | Yes | ||||
Expired US Patents for NDA 209176
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mitsubishi Tanabe | RADICAVA | edaravone | SOLUTION;INTRAVENOUS | 209176-001 | May 5, 2017 | 6,933,310 | ⤷ Get Started Free |
| Mitsubishi Tanabe | RADICAVA | edaravone | SOLUTION;INTRAVENOUS | 209176-002 | Nov 15, 2018 | 6,933,310 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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