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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Fish and Richardson

Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207963

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NDA 207963 describes PALONOSETRON HYDROCHLORIDE, which is a drug marketed by Dr Reddys Labs Ltd, Sandoz Inc, Teva Pharms Usa, Exela Pharma Science, and Fresenius Kabi Usa, and is included in six NDAs. It is available from seven suppliers. Additional details are available on the PALONOSETRON HYDROCHLORIDE profile page.

The generic ingredient in PALONOSETRON HYDROCHLORIDE is palonosetron hydrochloride. There are twenty-one drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the palonosetron hydrochloride profile page.
Summary for 207963
Applicant:Exela Pharma Science
Ingredient:palonosetron hydrochloride
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details
Pharmacology for NDA: 207963
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 N 0143-9513-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)
Approval Date:Aug 22, 2016TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Queensland Health
Harvard Business School

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