Details for New Drug Application (NDA): 217565
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NDA 217565 describes EDARAVONE, which is a drug marketed by Dr Reddys, Gland Pharma Ltd, Hikma, Long Grove Pharms, and Xgen Pharms, and is included in five NDAs. It is available from four suppliers. Additional details are available on the EDARAVONE profile page.
The generic ingredient in EDARAVONE is edaravone. Five suppliers are listed for this compound. Additional details are available on the edaravone profile page.
The generic ingredient in EDARAVONE is edaravone. Five suppliers are listed for this compound. Additional details are available on the edaravone profile page.
Summary for 217565
| Tradename: | EDARAVONE |
| Applicant: | Xgen Pharms |
| Ingredient: | edaravone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 217565
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EDARAVONE | edaravone | SOLUTION;INTRAVENOUS | 217565 | ANDA | XGen Pharmaceuticals DJB, Inc. | 39822-4500 | 39822-4500-2 | 1 VIAL, SINGLE-DOSE in 1 CARTON (39822-4500-2) / 100 mL in 1 VIAL, SINGLE-DOSE (39822-4500-1) |
| EDARAVONE | edaravone | SOLUTION;INTRAVENOUS | 217565 | ANDA | XGen Pharmaceuticals DJB, Inc. | 39822-4510 | 39822-4510-2 | 1 VIAL, SINGLE-DOSE in 1 CARTON (39822-4510-2) / 100 mL in 1 VIAL, SINGLE-DOSE (39822-4510-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 30MG/100ML (0.3MG/ML) | ||||
| Approval Date: | Oct 31, 2024 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 60MG/100ML (0.6MG/ML) | ||||
| Approval Date: | Oct 31, 2024 | TE: | AP | RLD: | No | ||||
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