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 five 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.
The generic ingredient in RENACIDIN is citric acid; gluconolactone; magnesium carbonate. There are five 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
| Tradename: | RENACIDIN |
| Applicant: | United Guardian |
| Ingredient: | citric acid; gluconolactone; magnesium carbonate |
| Patents: | 0 |
Pharmacology for NDA: 019481
| Mechanism of Action | Acidifying Activity Calcium Chelating Activity Irrigation |
| Physiological Effect | Decreased Coagulation Factor Activity |
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: | RX | Dosage: | SOLUTION;IRRIGATION | Strength | 6.602GM/100ML;198MG/100ML;3.177GM/100ML | ||||
| Approval Date: | Oct 2, 1990 | TE: | RLD: | Yes | |||||
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