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 020220

Tradename:	ULTRAVIST 370
Applicant:	Bayer Hlthcare
Ingredient:	iopromide
Patents:	0

Pharmacology for NDA: 020220

Mechanism of Action	X-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.	50419-344	50419-344-05	10 VIAL, GLASS in 1 CARTON (50419-344-05) / 50 mL in 1 VIAL, GLASS
ULTRAVIST 150	iopromide	INJECTABLE;INJECTION	020220	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-344	50419-344-10	10 VIAL, GLASS in 1 CARTON (50419-344-10) / 100 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	76.9%
Approval Date:	May 10, 1995	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	62.3%
Approval Date:	May 10, 1995	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	49.9%
Approval Date:	May 10, 1995	TE:		RLD:	Yes

Expired US Patents for NDA 020220

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	ULTRAVIST 370	iopromide	INJECTABLE;INJECTION	020220-001	May 10, 1995	4,364,921	⤷ Subscribe
Bayer Hlthcare	ULTRAVIST 150	iopromide	INJECTABLE;INJECTION	020220-004	May 10, 1995	4,364,921	⤷ Subscribe
Bayer Hlthcare	ULTRAVIST 300	iopromide	INJECTABLE;INJECTION	020220-002	May 10, 1995	4,364,921	⤷ Subscribe
Bayer Hlthcare	ULTRAVIST 240	iopromide	INJECTABLE;INJECTION	020220-003	May 10, 1995	4,364,921	⤷ Subscribe
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