Details for New Drug Application (NDA): 215446
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NDA 215446 describes RADICAVA ORS, which is a drug marketed by Shionogi and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the RADICAVA ORS profile page.
The generic ingredient in RADICAVA ORS is edaravone. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the edaravone profile page.
The generic ingredient in RADICAVA ORS is edaravone. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the edaravone profile page.
Summary for 215446
| Tradename: | RADICAVA ORS |
| Applicant: | Shionogi |
| Ingredient: | edaravone |
| Patents: | 12 |
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 | Shionogi 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 | Shionogi 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, 2029 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Nov 1, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Nov 1, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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