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Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201533

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NDA 201533 describes PALONOSETRON HYDROCHLORIDE, which is a drug marketed by Dr Reddys Labs Ltd, Sandoz Inc, Exela Pharma Science, and Fresenius Kabi Usa, and is included in five NDAs. It is available from two 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. Three suppliers are listed for this compound. Additional details are available on the palonosetron hydrochloride profile page.
Summary for 201533
Applicant:Dr Reddys Labs Ltd
Ingredient:palonosetron hydrochloride
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)
Approval Date:Apr 21, 2016TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
Approval Date:Apr 21, 2016TE:APRLD:No

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