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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 077557


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NDA 077557 describes ONDANSETRON, which is a drug marketed by Aurobindo Pharma, Barr, Chartwell Molecules, Glenmark Pharms Ltd, Ipca Labs Ltd, Mylan, Nesher Pharms, Sandoz, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, 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, Steriscience Speclts, Sun Pharm Inds (in), Wockhardt, Amneal Pharms, Pharm Assoc, Taro, Apotex, Chartwell Rx, Dr Reddys Labs Ltd, Hikma Intl Pharms, Natco Pharma Ltd, and Taro Pharms Ireland, and is included in seventy-nine NDAs. It is available from thirty-six suppliers. Additional details are available on the ONDANSETRON profile page.

The generic ingredient in ONDANSETRON 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 077557
Tradename:ONDANSETRON
Applicant:Sun Pharm Inds
Ingredient:ondansetron
Patents:0
Pharmacology for NDA: 077557
Medical Subject Heading (MeSH) Categories for 077557
Suppliers and Packaging for NDA: 077557
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 077557 ANDA Quality Care Products LLC 35356-197 35356-197-65 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (35356-197-65)
ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 077557 ANDA A-S Medication Solutions 50090-5346 50090-5346-0 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (50090-5346-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength4MG
Approval Date:Aug 2, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength8MG
Approval Date:Aug 2, 2007TE:ABRLD:No

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