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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 078257


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NDA 078257 describes ONDANSETRON HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Am Regent, Apotex Inc, Avet Lifesciences, Baxter Hlthcare Corp, Chartwell Molecular, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hikma Farmaceutica, Hospira, Lannett Co Inc, Luitpold, Pliva Hrvatska Doo, Qilu Pharm Hainan, Rising, Sagent Pharms, Sandoz, Steriscience Speclts, Sun Pharm Inds (in), Teva, Wockhardt, Amneal Pharms, Aurobindo Pharma, Pharm Assoc, Taro, Apotex, Chartwell Molecules, Chartwell Rx, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hikma Intl Pharms, Ipca Labs Ltd, Natco Pharma Ltd, Sun Pharm Inds Ltd, and Taro Pharms Ireland, and is included in sixty-eight NDAs. It is available from sixty-four suppliers. Additional details are available on the ONDANSETRON HYDROCHLORIDE profile page.

The generic ingredient in ONDANSETRON HYDROCHLORIDE is ondansetron hydrochloride. There are twenty-eight drug master file entries for this compound. Sixty-six suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
Summary for 078257
Pharmacology for NDA: 078257
Suppliers and Packaging for NDA: 078257
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 078257 ANDA Steriscience Specialties Private Limited 82449-201 82449-201-01 1 VIAL, MULTI-DOSE in 1 CARTON (82449-201-01) / 20 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML
Approval Date:Apr 23, 2008TE:RLD:No

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