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Generated: June 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203050

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NDA 203050 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 203050
Applicant:Dr Reddys Labs Ltd
Ingredient:palonosetron hydrochloride
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrengthEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)
Approval Date:Mar 1, 2016TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrengthEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
Approval Date:Mar 1, 2016TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Federal Trade Commission
Cantor Fitzgerald

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