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Generated: November 17, 2018

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Details for New Drug Application (NDA): 020605

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NDA 020605 describes ZOFRAN, which is a drug marketed by Novartis Pharms Corp and Glaxosmithkline and is included in five NDAs. It is available from two suppliers. Additional details are available on the ZOFRAN profile page.

The generic ingredient in ZOFRAN is ondansetron. There are twenty-eight drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the ondansetron profile page.
Summary for 020605
Tradename:ZOFRAN
Applicant:Novartis Pharms Corp
Ingredient:ondansetron hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020605
Suppliers and Packaging for NDA: 020605
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOFRAN ondansetron hydrochloride SOLUTION;ORAL 020605 NDA GlaxoSmithKline LLC 0173-0489 0173-0489-00 50 mL in 1 BOTTLE, GLASS (0173-0489-00)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 4MG BASE/5ML
Approval Date:Jan 24, 1997TE:AARLD:Yes

Expired US Patents for NDA 020605

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp ZOFRAN ondansetron hydrochloride SOLUTION;ORAL 020605-001 Jan 24, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp ZOFRAN ondansetron hydrochloride SOLUTION;ORAL 020605-001 Jan 24, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp ZOFRAN ondansetron hydrochloride SOLUTION;ORAL 020605-001 Jan 24, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Fish and Richardson
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Citi

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