Renacidin

NDA 19481, held by United Guardian. Citric Acid; Gluconolactone; Magnesium Carbonate.

As of Nov 13, 2026, NDA 19481 (Renacidin), held by United Guardian, was first approved by FDA on Oct 2, 1990, with 10 approved supplements and 0 published complete response letters.

First approved: Oct 2, 1990
Review: Priority
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Renacidin is indicated for dissolution of bladder calculi of the struvite or apatite variety by local intermittent irrigation through a urethral catheter or cystostomy tube as an alternative or adjunct to surgical procedures. Renacidin is also indicated for use as an intermittent irrigating solution to prevent encrustations of indwelling urethral catheters and cystostomy tubes.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Oct 2, 1990	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Renacidin6.602GM/100ML;198MG/100ML;3.177GM/100ML · solution;irrigation	Citric Acid; Gluconolactone; Magnesium Carbonate	RxReference drug

All 11 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 16, 2015	Supplement 12Manufacturing · Priority review	Approved	None posted
Oct 30, 2015	Supplement 13Labeling · Standard review	Approved	Letter Label
Feb 12, 2014	Supplement 11Manufacturing · Priority review	Approved	None posted
May 3, 2007	Supplement 7Manufacturing	Approved	Letter
Sep 30, 1998	Supplement 6Manufacturing · Priority review	Approved	None posted
Aug 31, 1998	Supplement 5Manufacturing · Priority review	Approved	None posted
Oct 28, 1996	Supplement 4Manufacturing · Priority review	Approved	None posted
Dec 3, 1993	Supplement 3Manufacturing · Priority review	Approved	None posted
Apr 16, 1993	Supplement 1Manufacturing · Priority review	Approved	None posted
Apr 13, 1993	Supplement 2Manufacturing · Priority review	Approved	None posted
Oct 2, 1990	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 19481
Drugs@FDA: Overview at FDA
Company: United-Guardian

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters