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Johnson and Johnson
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Federal Trade Commission
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Generated: April 19, 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, Teva Pharms Usa, Exela Pharma Science, and Fresenius Kabi Usa, and is included in six NDAs. It is available from five 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. Eight 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 Labs Ltd
Ingredient:palonosetron hydrochloride
Patents:0
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details
Pharmacology for NDA: 201533
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 Dr.Reddy's Laboratories Limited 55111-694 N 55111-694-07
PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride INJECTABLE;INTRAVENOUS 201533 ANDA Dr.Reddy's Laboratories Limited 55111-694 N 55111-694-19

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
Regulatory Exclusivity Expiration:Sep 19, 2018
Regulatory Exclusivity Use:PATENT CHALLENGE

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
Regulatory Exclusivity Expiration:Sep 19, 2018
Regulatory Exclusivity Use:PATENT CHALLENGE

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Daiichi Sankyo
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