Details for New Drug Application (NDA): 216199
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NDA 216199 describes EDARAVONE, which is a drug marketed by Dr Reddys, Gland Pharma Ltd, Hikma, and Long Grove Pharms, and is included in four NDAs. It is available from three suppliers. Additional details are available on the EDARAVONE profile page.
The generic ingredient in EDARAVONE is edaravone. Four suppliers are listed for this compound. Additional details are available on the edaravone profile page.
The generic ingredient in EDARAVONE is edaravone. Four suppliers are listed for this compound. Additional details are available on the edaravone profile page.
Summary for 216199
| Tradename: | EDARAVONE |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | edaravone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216199
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EDARAVONE | edaravone | SOLUTION;INTRAVENOUS | 216199 | ANDA | Piramal Critical Care Inc. | 66794-259 | 66794-259-64 | 2 POUCH in 1 CARTON (66794-259-64) / 1 BAG in 1 POUCH / 100 mL in 1 BAG |
| EDARAVONE | edaravone | SOLUTION;INTRAVENOUS | 216199 | ANDA | Gland Pharma Limited | 68083-500 | 68083-500-02 | 2 POUCH in 1 CARTON (68083-500-02) / 1 BAG in 1 POUCH / 100 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 30MG/100ML (0.3MG/ML) | ||||
| Approval Date: | May 6, 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: | May 6, 2024 | TE: | AP | RLD: | No | ||||
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