Details for New Drug Application (NDA): 203050
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The generic ingredient in PALONOSETRON HYDROCHLORIDE 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: | PALONOSETRON HYDROCHLORIDE |
Applicant: | Avyxa Holdings |
Ingredient: | palonosetron hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
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: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | ||||
Approval Date: | Mar 1, 2016 | TE: | RLD: | No |
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