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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 077851


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NDA 077851 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, 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 077851
Tradename:ONDANSETRON HYDROCHLORIDE
Applicant:Natco Pharma Ltd
Ingredient:ondansetron hydrochloride
Patents:0
Pharmacology for NDA: 077851
Suppliers and Packaging for NDA: 077851
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077851 ANDA ACTAVIS PHARMA, INC. 45963-538 45963-538-30 30 TABLET, FILM COATED in 1 BOTTLE (45963-538-30)
ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077851 ANDA ACTAVIS PHARMA, INC. 45963-539 45963-539-30 30 TABLET, FILM COATED in 1 BOTTLE (45963-539-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Jun 25, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 8MG BASE
Approval Date:Jun 25, 2007TE:ABRLD:No

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