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Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090713

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NDA 090713 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 090713
Tradename:PALONOSETRON HYDROCHLORIDE
Applicant:Teva Pharms Usa
Ingredient:palonosetron hydrochloride
Patents:0
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details
Pharmacology for NDA: 090713
Suppliers and Packaging for NDA: 090713
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride INJECTABLE;INTRAVENOUS 090713 ANDA Teva Parenteral Medicines, Inc. 0703-4094 N 0703-4094-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
Approval Date:Mar 23, 2018TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)
Approval Date:Mar 23, 2018TE:APRLD:No
Regulatory Exclusivity Expiration:Sep 19, 2018
Regulatory Exclusivity Use:PATENT CHALLENGE

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