Details for New Drug Application (NDA): 215446
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NDA 215446 describes RADICAVA ORS, which is a drug marketed by Kk Bcj-94 and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the RADICAVA ORS profile page.
The generic ingredient in RADICAVA ORS is edaravone. Six suppliers are listed for this compound. Additional details are available on the edaravone profile page.
The generic ingredient in RADICAVA ORS is edaravone. Six suppliers are listed for this compound. Additional details are available on the edaravone profile page.
Summary for 215446
| Tradename: | RADICAVA ORS |
| Applicant: | Kk Bcj-94 |
| Ingredient: | edaravone |
| Patents: | 8 |
Suppliers and Packaging for NDA: 215446
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RADICAVA ORS | edaravone | SUSPENSION;ORAL | 215446 | NDA | Mitsubishi Tanabe Pharma America, Inc. | 70510-2321 | 70510-2321-2 | 2 CARTON in 1 CARTON (70510-2321-2) / 1 KIT in 1 CARTON (70510-2321-1) * 1 BOTTLE in 1 KIT (70510-2323-1) / 35 mL in 1 BOTTLE |
| RADICAVA ORS | edaravone | SUSPENSION;ORAL | 215446 | NDA | Mitsubishi Tanabe Pharma America, Inc. | 70510-2322 | 70510-2322-1 | 1 KIT in 1 CARTON (70510-2322-1) * 50 mL in 1 BOTTLE (70510-2324-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 105MG/5ML | ||||
| Approval Date: | May 12, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 12, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Regulatory Exclusivity Expiration: | May 12, 2029 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) | ||||||||
| Patent: | 10,987,341 | Patent Expiration: | Nov 1, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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