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Generated: October 20, 2017

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 NDA: 021425

Tradename:
1
Applicant:
1
Ingredient:
1
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 50419-342-21 10 BOTTLE in 1 PACKAGE (50419-342-21) > 200 mL in 1 BOTTLE
ULTRAVIST (PHARMACY BULK)
iopromide
INJECTABLE;INJECTION 021425 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-342 50419-342-05 10 VIAL, GLASS in 1 CARTON (50419-342-05) > 50 mL in 1 VIAL, GLASS

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

Expired Orange Book Patents for NDA: 021425

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
ULTRAVIST (PHARMACY BULK)
iopromide
INJECTABLE;INJECTION021425-001Sep 20, 2002► Subscribe► Subscribe
Bayer Hlthcare
ULTRAVIST (PHARMACY BULK)
iopromide
INJECTABLE;INJECTION021425-003Mar 12, 2004► Subscribe► Subscribe
Bayer Hlthcare
ULTRAVIST (PHARMACY BULK)
iopromide
INJECTABLE;INJECTION021425-002Sep 20, 2002► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Mallinckrodt
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Dow
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Queensland Health
Harvard Business School
Accenture

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