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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Cipla
Queensland Health
Fish and Richardson
McKesson
Colorcon
Dow
Citi
Moodys
Mallinckrodt

Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021425

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NDA 021425 describes ULTRAVIST (PHARMACY BULK), which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the ULTRAVIST (PHARMACY BULK) profile page.

The generic ingredient in ULTRAVIST (PHARMACY BULK) is iopromide. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the iopromide profile page.
Summary for 021425
Tradename:ULTRAVIST (PHARMACY BULK)
Applicant:Bayer Hlthcare
Ingredient:iopromide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021425
Mechanism of ActionX-Ray Contrast Activity
Suppliers and Packaging for NDA: 021425
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ULTRAVIST (PHARMACY BULK) iopromide INJECTABLE;INJECTION 021425 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-342 N 50419-342-21
ULTRAVIST (PHARMACY BULK) iopromide INJECTABLE;INJECTION 021425 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-342 N 50419-342-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength62.3%
Approval Date:Sep 20, 2002TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength76.9%
Approval Date:Sep 20, 2002TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength49.9%
Approval Date:Mar 12, 2004TE:RLD:Yes

Expired US Patents for NDA 021425

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare ULTRAVIST (PHARMACY BULK) iopromide INJECTABLE;INJECTION 021425-001 Sep 20, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Bayer Hlthcare ULTRAVIST (PHARMACY BULK) iopromide INJECTABLE;INJECTION 021425-002 Sep 20, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Bayer Hlthcare ULTRAVIST (PHARMACY BULK) iopromide INJECTABLE;INJECTION 021425-003 Mar 12, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Fuji
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Chubb
Daiichi Sankyo
Covington
Moodys
AstraZeneca
Cipla
Express Scripts

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