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Last Updated: June 18, 2024

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
Formulation / Manufacturing:see details
Pharmacology for NDA: 020923
Mechanism of ActionX-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:DISCNDosage:INJECTABLE;INJECTIONStrength51%
Approval Date:May 28, 1998TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength68%
Approval Date:May 29, 1998TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength74%
Approval Date:May 28, 1998TE:RLD:Yes

Expired US Patents for NDA 020923

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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