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Details for New Drug Application (NDA): 013295

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NDA 013295 describes CONRAY 43, which is a drug marketed by Liebel-flarsheim and is included in one NDA. It is available from one supplier. Additional details are available on the CONRAY 43 profile page.

The generic ingredient in CONRAY 43 is iothalamate meglumine. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the iothalamate meglumine profile page.

Summary for NDA: 013295

Tradename:
CONRAY
Applicant:
Liebel-flarsheim
Ingredient:
iothalamate meglumine
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 013295

Mechanism of ActionX-Ray Contrast Activity

Suppliers and Packaging for NDA: 013295

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CONRAY
iothalamate meglumine
INJECTABLE;INJECTION 013295 NDA Liebel-Flarsheim Company LLC 0019-0953 0019-0953-03 12 VIAL, GLASS in 1 BOX (0019-0953-03) > 100 mL in 1 VIAL, GLASS
CONRAY
iothalamate meglumine
INJECTABLE;INJECTION 013295 NDA Liebel-Flarsheim Company LLC 0019-0953 0019-0953-05 25 VIAL, GLASS in 1 BOX (0019-0953-05) > 50 mL in 1 VIAL, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength60%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength43%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes


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