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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 three 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 NDA: 019481

United Guardian
citric acid; gluconolactone; magnesium carbonate
Formulation / Manufacturing:see details

Pharmacology for NDA: 019481

Suppliers and Packaging for NDA: 019481

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
citric acid; gluconolactone; magnesium carbonate
SOLUTION;IRRIGATION 019481 NDA United-Guardian, Inc. 0327-0011 0327-0011-05 500 mL in 1 BOTTLE (0327-0011-05)
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

Summary 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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