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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 020316

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NDA 020316 describes OXILAN-350, which is a drug marketed by Guerbet and is included in one NDA. Additional details are available on the OXILAN-350 profile page.

The generic ingredient in OXILAN-350 is ioxilan. There is one drug master file entry for this compound. Additional details are available on the ioxilan profile page.

Summary for 020316

Tradename:	OXILAN-350
Applicant:	Guerbet
Ingredient:	ioxilan
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	62%
Approval Date:	Dec 21, 1995	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	73%
Approval Date:	Dec 21, 1995	TE:		RLD:	No

Expired US Patents for NDA 020316

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Guerbet	OXILAN-300	ioxilan	INJECTABLE;INJECTION	020316-001	Dec 21, 1995	4,954,348	⤷ Start Trial
Guerbet	OXILAN-350	ioxilan	INJECTABLE;INJECTION	020316-002	Dec 21, 1995	4,954,348	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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