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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 090469


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NDA 090469 describes ONDANSETRON, which is a drug marketed by Aurobindo Pharma, Barr, Chartwell Molecules, Glenmark Generics, Ipca Labs Ltd, Mylan, Nesher Pharms, Sandoz, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, Accord Hlthcare, 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, Sun Pharm Inds (in), Wockhardt, Amneal Pharms, Pharm Assoc, Taro, Apotex, Casi Pharms Inc, Dr Reddys Labs Ltd, Hikma Intl Pharms, Natco Pharma Ltd, Am Regent, and Taro Pharms Ireland, and is included in seventy-nine NDAs. It is available from thirty-four 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-two suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
Summary for 090469
Tradename:ONDANSETRON
Applicant:Aurobindo Pharma
Ingredient:ondansetron
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090469
Medical Subject Heading (MeSH) Categories for 090469
Suppliers and Packaging for NDA: 090469
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 090469 ANDA NorthStar Rx LLC 16714-200 16714-200-30 3 BLISTER PACK in 1 CARTON (16714-200-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (16714-200-10)
ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 090469 ANDA NorthStar Rx LLC 16714-201 16714-201-10 1 BLISTER PACK in 1 CARTON (16714-201-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength4MG
Approval Date:Apr 12, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength8MG
Approval Date:Apr 12, 2010TE:ABRLD:No

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