Lithostat

For chronic urea-splitting urinary infection. NDA 18749, held by Mission Pharma. Acetohydroxamic Acid.

As of Nov 14, 2026, NDA 18749 (Lithostat), held by Mission Pharma, was first approved by FDA on May 31, 1983, with 7 approved supplements and 0 published complete response letters.

First approved: May 31, 1983
Review: Priority
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Acetohydroxamic acid is indicated as adjunctive therapy in patients with chronic urea-splitting urinary infection. AHA is intended to decrease urinary ammonia and alkalinity, but it should not be used in lieu of curative surgical treatment (for patients with stones) or antimicrobial treatment. Long-term treatment with AHA may be warranted to maintain urease inhibition as long as urea-splitting infection is present. Experience with AHA does not go beyond 7 years. A patient package insert should be distributed to each patient who receives AHA.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
May 31, 1983	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lithostat250MG · tablet;oral	Acetohydroxamic Acid	RxReference drug

All 8 submissions, including labeling and manufacturing supplements


Jan 26, 2015	Supplement 9Manufacturing · Priority review	Approved	None posted
May 19, 2000	Supplement 7Manufacturing · Priority review	Approved	None posted
Aug 3, 1988	Supplement 6Labeling	Approved	None posted
Aug 6, 1986	Supplement 4Manufacturing · Priority review	Approved	None posted
Nov 5, 1984	Supplement 2Manufacturing · Priority review	Approved	None posted
Jan 11, 1984	Supplement 3Manufacturing · Priority review	Approved	None posted
Nov 18, 1983	Supplement 1Labeling	Approved	None posted
May 31, 1983	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 18749
Drugs@FDA: Overview at FDA
Company: Mission Pharma

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