Details for New Drug Application (NDA): 201533
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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 201533
Tradename: | PALONOSETRON HYDROCHLORIDE |
Applicant: | Dr Reddys |
Ingredient: | palonosetron hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 201533
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 201533
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 201533 | ANDA | NorthStar Rx LLC | 16714-834 | 16714-834-01 | 1 VIAL, SINGLE-USE in 1 CARTON (16714-834-01) / 5 mL in 1 VIAL, SINGLE-USE |
PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 201533 | ANDA | Dr.Reddy's Laboratories Limited | 55111-694 | 55111-694-07 | 1 VIAL, SINGLE-USE in 1 CARTON (55111-694-07) / 5 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) | ||||
Approval Date: | Apr 21, 2016 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | ||||
Approval Date: | Apr 21, 2016 | TE: | AP | RLD: | No |
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