Details for New Drug Application (NDA): 203050
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NDA 203050 describes POSFREA, which is a drug marketed by Avyxa Holdings and is included in one NDA. It is available from one supplier. Additional details are available on the POSFREA profile page.
The generic ingredient in POSFREA is palonosetron hydrochloride. There are twenty-one drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the palonosetron hydrochloride profile page.
The generic ingredient in POSFREA is palonosetron hydrochloride. There are twenty-one drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the palonosetron hydrochloride profile page.
Summary for 203050
| Tradename: | POSFREA |
| Applicant: | Avyxa Holdings |
| Ingredient: | palonosetron hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 203050
| Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 203050
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POSFREA | palonosetron hydrochloride | SOLUTION;INTRAVENOUS | 203050 | NDA | Avyxa Pharma, LLC | 83831-105 | 83831-105-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (83831-105-01) / 5 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) | ||||
| Approval Date: | Mar 1, 2016 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | ||||
| Approval Date: | Mar 1, 2016 | TE: | RLD: | Yes | |||||
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