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Details for New Drug Application (NDA): 020220

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NDA 020220 describes ULTRAVIST 370, 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 370 profile page.

The generic ingredient in ULTRAVIST 370 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: 020220

Tradename:
5
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 020220

Mechanism of ActionX-Ray Contrast Activity

Suppliers and Packaging for NDA: 020220

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ULTRAVIST 150
iopromide
INJECTABLE;INJECTION 020220 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-340 50419-340-05 10 VIAL, GLASS in 1 CARTON (50419-340-05) > 50 mL in 1 VIAL, GLASS
ULTRAVIST 150
iopromide
INJECTABLE;INJECTION 020220 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-342 50419-342-21 10 BOTTLE in 1 PACKAGE (50419-342-21) > 200 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength76.9%
Approval Date:May 10, 1995TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength62.3%
Approval Date:May 10, 1995TE:RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength49.9%
Approval Date:May 10, 1995TE:RLD:Yes

Expired Orange Book Patents for NDA: 020220

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
ULTRAVIST 370
iopromide
INJECTABLE;INJECTION020220-001May 10, 19954,364,921► Subscribe
Bayer Hlthcare
ULTRAVIST 300
iopromide
INJECTABLE;INJECTION020220-002May 10, 19954,364,921► Subscribe
Bayer Hlthcare
ULTRAVIST 150
iopromide
INJECTABLE;INJECTION020220-004May 10, 19954,364,921► Subscribe
Bayer Hlthcare
ULTRAVIST 240
iopromide
INJECTABLE;INJECTION020220-003May 10, 19954,364,921► Subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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