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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 207963


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NDA 207963 describes PALONOSETRON HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Avet Lifesciences, Baxter Hlthcare Corp, Chartwell Rx, Cipla, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Meitheal, Mylan Institutional, Novast Labs, Qilu Pharm Hainan, Sagent Pharms Inc, Sandoz, Teva Pharms Usa, and Hikma, and is included in twenty NDAs. It is available from twenty 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. Twenty-one suppliers are listed for this compound. Additional details are available on the palonosetron hydrochloride profile page.
Summary for 207963
Tradename:PALONOSETRON HYDROCHLORIDE
Applicant:Hikma
Ingredient:palonosetron hydrochloride
Patents:0
Pharmacology for NDA: 207963
Suppliers and Packaging for NDA: 207963
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride SOLUTION;INTRAVENOUS 207963 NDA West-Ward Pharmaceuticals Corp 0143-9513 0143-9513-01 2 mL in 1 VIAL (0143-9513-01)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrengthEQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)
Approval Date:Aug 22, 2016TE:RLD:No

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