Details for New Drug Application (NDA): 209287
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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 209287
Tradename: | PALONOSETRON HYDROCHLORIDE |
Applicant: | Chartwell Rx |
Ingredient: | palonosetron hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209287
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 209287
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 209287 | ANDA | Virtus Pharmaceuticals, LLC | 69543-371 | 69543-371-10 | 10 CARTON in 1 BOX (69543-371-10) / 1 VIAL in 1 CARTON (69543-371-01) / 5 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | ||||
Approval Date: | Sep 19, 2018 | TE: | AP | RLD: | No |
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