Details for New Drug Application (NDA): 207963
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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 207963
Tradename: | PALONOSETRON HYDROCHLORIDE |
Applicant: | Hikma |
Ingredient: | palonosetron hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 207963
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 207963
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | SOLUTION;INTRAVENOUS | 207963 | NDA | West-Ward Pharmaceuticals Corp | 0143-9513 | 0143-9513-01 | 2 mL in 1 VIAL (0143-9513-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML) | ||||
Approval Date: | Aug 22, 2016 | TE: | RLD: | No |
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