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Details for New Drug Application (NDA): 017057

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NDA 017057 describes CYSTO-CONRAY II, 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 CYSTO-CONRAY II profile page.

The generic ingredient in CYSTO-CONRAY II 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: 017057

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

Pharmacology for NDA: 017057

Mechanism of ActionX-Ray Contrast Activity

Suppliers and Packaging for NDA: 017057

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYSTO-CONRAY II
iothalamate meglumine
SOLUTION;INTRAVESICAL 017057 NDA Liebel-Flarsheim Company LLC 0019-0862 0019-0862-07 12 BOTTLE, GLASS in 1 BOX (0019-0862-07) > 250 mL in 1 BOTTLE, GLASS
CYSTO-CONRAY II
iothalamate meglumine
SOLUTION;INTRAVESICAL 017057 NDA Liebel-Flarsheim Company LLC 0019-0862 0019-0862-50 12 BOTTLE, GLASS in 1 BOX (0019-0862-50) > 250 mL in 1 BOTTLE, GLASS

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVESICALStrength17.2%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No


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