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Details for New Drug Application (NDA): 204078
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NDA 204078 describes BLOXIVERZ, which is a drug marketed by Avadel Legacy and is included in one NDA. It is available from two suppliers. Additional details are available on the BLOXIVERZ profile page.
The generic ingredient in BLOXIVERZ is neostigmine methylsulfate. There are nine drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the neostigmine methylsulfate profile page.
The generic ingredient in BLOXIVERZ is neostigmine methylsulfate. There are nine drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the neostigmine methylsulfate profile page.
Summary for 204078
| Tradename: | BLOXIVERZ |
| Applicant: | Avadel Legacy |
| Ingredient: | neostigmine methylsulfate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204078
| Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for 204078
Suppliers and Packaging for NDA: 204078
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BLOXIVERZ | neostigmine methylsulfate | SOLUTION;INTRAVENOUS | 204078 | NDA | BluePoint Laboratories | 68001-329 | 68001-329-67 | 10 CARTON in 1 PACKAGE (68001-329-67) > 1 VIAL, MULTI-DOSE in 1 CARTON (68001-329-66) > 10 mL in 1 VIAL, MULTI-DOSE |
| BLOXIVERZ | neostigmine methylsulfate | SOLUTION;INTRAVENOUS | 204078 | NDA | Avadel Legacy Pharmaceuticals, LLC | 76014-002 | 76014-002-10 | 10 CARTON in 1 PACKAGE (76014-002-10) > 1 VIAL, MULTI-DOSE in 1 CARTON (76014-002-33) > 10 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 5MG/10ML (0.5MG/ML) | ||||
| Approval Date: | May 31, 2013 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10MG/10ML (1MG/ML) | ||||
| Approval Date: | May 31, 2013 | TE: | AP | RLD: | Yes | ||||
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