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Generated: January 18, 2019

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Details for New Drug Application (NDA): 019481

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NDA 019481 describes RENACIDIN, which is a drug marketed by United Guardian and is included in one NDA. It is available from one supplier. Additional details are available on the RENACIDIN profile page.

The generic ingredient in RENACIDIN is citric acid; gluconolactone; magnesium carbonate. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the citric acid; gluconolactone; magnesium carbonate profile page.
Summary for 019481
Pharmacology for NDA: 019481
Suppliers and Packaging for NDA: 019481
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RENACIDIN citric acid; gluconolactone; magnesium carbonate SOLUTION;IRRIGATION 019481 NDA United-Guardian, Inc. 0327-0012 0327-0012-30 30 BOTTLE in 1 CARTON (0327-0012-30) > 30 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IRRIGATIONStrength6.602GM/100ML;198MG/100ML;3.177GM/100ML
Approval Date:Oct 2, 1990TE:RLD:Yes

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