Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 21, 2019

DrugPatentWatch Database Preview

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
Formulation / Manufacturing:see details
Pharmacology for NDA: 019710
Mechanism of ActionX-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:RXDosage:INJECTABLE;INJECTIONStrength68%
Approval Date:Dec 30, 1988TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength51%
Approval Date:Dec 30, 1988TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength34%
Approval Date:Dec 30, 1988TE:RLD:No

Expired US Patents for NDA 019710

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Liebel-flarsheim OPTIRAY 160 ioversol INJECTABLE;INJECTION 019710-003 Dec 30, 1988   Start Trial   Start Trial
Liebel-flarsheim OPTIRAY 320 ioversol INJECTABLE;INJECTION 019710-001 Dec 30, 1988   Start Trial   Start Trial
Liebel-flarsheim OPTIRAY 350 ioversol INJECTABLE;INJECTION 019710-005 Jan 22, 1992   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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