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. 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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	62.3%
Approval Date:	Sep 20, 2002	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	76.9%
Approval Date:	Sep 20, 2002	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	49.9%
Approval Date:	Mar 12, 2004	TE:		RLD:	Yes

Expired US Patents for NDA 021425

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	ULTRAVIST (PHARMACY BULK)	iopromide	INJECTABLE;INJECTION	021425-003	Mar 12, 2004	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	ULTRAVIST (PHARMACY BULK)	iopromide	INJECTABLE;INJECTION	021425-002	Sep 20, 2002	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	ULTRAVIST (PHARMACY BULK)	iopromide	INJECTABLE;INJECTION	021425-001	Sep 20, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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