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Generated: September 21, 2017

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Details for New Drug Application (NDA): 207963

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NDA 207963 describes PALONOSETRON HYDROCHLORIDE, which is a drug marketed by Sandoz Inc, Dr Reddys Labs Ltd, and Exela Pharma Science, and is included in four NDAs. 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. One supplier is listed for this compound. Additional details are available on the palonosetron hydrochloride profile page.

Summary for NDA: 207963

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details

Summary 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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