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Details for New Drug Application (NDA): 020007

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NDA 020007 describes ZOFRAN PRESERVATIVE FREE, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from one supplier. Additional details are available on the ZOFRAN PRESERVATIVE FREE profile page.

The generic ingredient in ZOFRAN PRESERVATIVE FREE is ondansetron hydrochloride. There are twenty-eight drug master file entries for this compound. Seventy suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the ondansetron hydrochloride profile page.

Summary for NDA: 020007

Tradename:
ZOFRAN
Applicant:
Novartis Pharms Corp
Ingredient:
ondansetron hydrochloride
Patents:0
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details

Pharmacology for NDA: 020007

Suppliers and Packaging for NDA: 020007

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOFRAN
ondansetron hydrochloride
INJECTABLE;INJECTION 020007 NDA GlaxoSmithKline LLC 0173-0442 0173-0442-00 20 mL in 1 VIAL (0173-0442-00)
ZOFRAN PRESERVATIVE FREE
ondansetron hydrochloride
INJECTABLE;INJECTION 020007 NDA GlaxoSmithKline LLC 0173-0442 0173-0442-00 20 mL in 1 VIAL (0173-0442-00)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML
Approval Date:Jan 4, 1991TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML
Approval Date:Dec 10, 1993TE:RLD:No

Expired Orange Book Patents for NDA: 020007

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp
ZOFRAN
ondansetron hydrochloride
INJECTABLE;INJECTION020007-001Jan 4, 19914,695,578*PED► subscribe
Novartis Pharms Corp
ZOFRAN PRESERVATIVE FREE
ondansetron hydrochloride
INJECTABLE;INJECTION020007-003Dec 10, 19934,753,789*PED► subscribe
Novartis Pharms Corp
ZOFRAN PRESERVATIVE FREE
ondansetron hydrochloride
INJECTABLE;INJECTION020007-003Dec 10, 19934,695,578*PED► subscribe
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