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Generated: May 28, 2017

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Details for New Drug Application (NDA): 019292

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NDA 019292 describes MD-76R, 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 MD-76R profile page.

The generic ingredient in MD-76R is diatrizoate meglumine; diatrizoate sodium. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the diatrizoate meglumine; diatrizoate sodium profile page.

Summary for NDA: 019292

Formulation / Manufacturing:see details

Pharmacology for NDA: 019292

Mechanism of ActionX-Ray Contrast Activity

Suppliers and Packaging for NDA: 019292

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
diatrizoate meglumine; diatrizoate sodium
INJECTABLE;INJECTION 019292 NDA Liebel-Flarsheim Company LLC 0019-1317 0019-1317-07 12 BOTTLE, GLASS in 1 BOX (0019-1317-07) > 100 mL in 1 BOTTLE, GLASS
diatrizoate meglumine; diatrizoate sodium
INJECTABLE;INJECTION 019292 NDA Liebel-Flarsheim Company LLC 0019-1317 0019-1317-09 12 BOTTLE, GLASS in 1 BOX (0019-1317-09) > 200 mL in 1 BOTTLE, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength66%;10%
Approval Date:Sep 29, 1989TE:APRLD:Yes

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