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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 205648


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NDA 205648 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 205648
Pharmacology for NDA: 205648
Suppliers and Packaging for NDA: 205648
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride INJECTABLE;INTRAVENOUS 205648 ANDA Apotex Corp. 60505-6193 60505-6193-1 1 VIAL in 1 CARTON (60505-6193-1) / 5 mL in 1 VIAL
PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride INJECTABLE;INTRAVENOUS 205648 ANDA Qilu Pharmaceutical Co., Ltd. 67184-0514 67184-0514-1 1 VIAL in 1 CARTON (67184-0514-1) / 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
Approval Date:Sep 19, 2018TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAVENOUSStrengthEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)
Approval Date:Sep 19, 2018TE:RLD:No

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