Details for New Drug Application (NDA): 216199
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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 |
Formulation / Manufacturing: | see details |
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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