Details for New Drug Application (NDA): 020923

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NDA 020923 describes OPTIRAY 350, which is a drug marketed by Liebel-flarsheim and is included in two NDAs. It is available from one supplier. Additional details are available on the OPTIRAY 350 profile page.

The generic ingredient in OPTIRAY 350 is ioversol. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ioversol profile page.

Summary for 020923

Tradename:	OPTIRAY 350
Applicant:	Liebel-flarsheim
Ingredient:	ioversol
Patents:	0

Pharmacology for NDA: 020923

Mechanism of Action	X-Ray Contrast Activity

Suppliers and Packaging for NDA: 020923

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OPTIRAY 240	ioversol	INJECTABLE;INJECTION	020923	NDA	Liebel-Flarsheim Company LLC	0019-1323	0019-1323-00	20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-00) / 100 mL in 1 SYRINGE, PLASTIC
OPTIRAY 240	ioversol	INJECTABLE;INJECTION	020923	NDA	Liebel-Flarsheim Company LLC	0019-1323	0019-1323-02	25 VIAL, GLASS in 1 CARTON (0019-1323-02) / 20 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	51%
Approval Date:	May 28, 1998	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	68%
Approval Date:	May 29, 1998	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	74%
Approval Date:	May 28, 1998	TE:		RLD:	Yes

Expired US Patents for NDA 020923

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Liebel-flarsheim	OPTIRAY 240	ioversol	INJECTABLE;INJECTION	020923-001	May 28, 1998	⤷ Sign Up	⤷ Sign Up
Liebel-flarsheim	OPTIRAY 350	ioversol	INJECTABLE;INJECTION	020923-003	May 28, 1998	⤷ Sign Up	⤷ Sign Up
Liebel-flarsheim	OPTIRAY 320	ioversol	INJECTABLE;INJECTION	020923-002	May 29, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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