Details for New Drug Application (NDA): 019710

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NDA 019710 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 019710

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

Pharmacology for NDA: 019710

Mechanism of Action	X-Ray Contrast Activity

Suppliers and Packaging for NDA: 019710

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OPTIRAY 160	ioversol	INJECTABLE;INJECTION	019710	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 160	ioversol	INJECTABLE;INJECTION	019710	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:	RX	Dosage:	INJECTABLE;INJECTION			Strength	68%
Approval Date:	Dec 30, 1988	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	51%
Approval Date:	Dec 30, 1988	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	34%
Approval Date:	Dec 30, 1988	TE:		RLD:	No

Expired US Patents for NDA 019710

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Liebel-flarsheim	OPTIRAY 350	ioversol	INJECTABLE;INJECTION	019710-005	Jan 22, 1992	4,396,598	⤷ Subscribe
Liebel-flarsheim	OPTIRAY 160	ioversol	INJECTABLE;INJECTION	019710-003	Dec 30, 1988	4,396,598	⤷ Subscribe
Liebel-flarsheim	OPTIRAY 320	ioversol	INJECTABLE;INJECTION	019710-001	Dec 30, 1988	4,396,598	⤷ Subscribe
Liebel-flarsheim	OPTIRAY 300	ioversol	INJECTABLE;INJECTION	019710-004	Jan 22, 1992	4,396,598	⤷ Subscribe
Liebel-flarsheim	OPTIRAY 240	ioversol	INJECTABLE;INJECTION	019710-002	Dec 30, 1988	4,396,598	⤷ Subscribe
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