Details for New Drug Application (NDA): 218354
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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 218354
Tradename: | EDARAVONE |
Applicant: | Long Grove Pharms |
Ingredient: | edaravone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 218354
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EDARAVONE | edaravone | SOLUTION;INTRAVENOUS | 218354 | ANDA | Long Grove Pharmaceuticals, LLC | 81298-7050 | 81298-7050-3 | 2 BAG in 1 CARTON (81298-7050-3) / 100 mL in 1 BAG (81298-7050-1) |
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 |
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