Details for New Drug Application (NDA): 202521
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The generic ingredient in PALONOSETRON HYDROCHLORIDE is palonosetron hydrochloride. There are twenty-one drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the palonosetron hydrochloride profile page.
Summary for 202521
Tradename: | PALONOSETRON HYDROCHLORIDE |
Applicant: | Sandoz |
Ingredient: | palonosetron hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202521
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 202521
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 202521 | ANDA | Sandoz Inc | 0781-3312 | 0781-3312-75 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3312-75) / 5 mL in 1 VIAL, SINGLE-DOSE |
PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 202521 | ANDA | Sandoz Inc | 0781-3415 | 0781-3415-75 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3415-75) / 5 mL in 1 VIAL, SINGLE-DOSE |
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: | Oct 13, 2015 | TE: | AP | RLD: | No |
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