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Generated: July 27, 2017

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 NDA: 019710

Tradename:
5
Applicant:
1
Ingredient:
1
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength68%
Approval Date:Dec 30, 1988TE:RLD:Yes

Summary for product number 002

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

Summary for product number 003

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

Expired Orange Book Patents for NDA: 019710

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Liebel-flarsheim
OPTIRAY 160
ioversol
INJECTABLE;INJECTION019710-003Dec 30, 1988► Subscribe► Subscribe
Liebel-flarsheim
OPTIRAY 300
ioversol
INJECTABLE;INJECTION019710-004Jan 22, 1992► Subscribe► Subscribe
Liebel-flarsheim
OPTIRAY 350
ioversol
INJECTABLE;INJECTION019710-005Jan 22, 1992► Subscribe► Subscribe
Liebel-flarsheim
OPTIRAY 320
ioversol
INJECTABLE;INJECTION019710-001Dec 30, 1988► Subscribe► Subscribe
Liebel-flarsheim
OPTIRAY 240
ioversol
INJECTABLE;INJECTION019710-002Dec 30, 1988► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Cantor Fitzgerald
Novartis
Moodys
McKesson
Chubb
Covington
Fuji
Merck
AstraZeneca

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