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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:
ULTRAVIST 150
Applicant:
Bayer Hlthcare
Ingredient:
iopromide
Patents:0
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

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
ULTRAVIST 150
iopromide
INJECTABLE;INJECTION020220-004May 10, 19954,364,921► subscribe
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
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