Rimso-50

Relieves interstitial cystitis. NDA 17788, held by Mylan Institutional. Dimethyl Sulfoxide.

As of Nov 13, 2026, NDA 17788 (Rimso-50), held by Mylan Institutional, was first approved by FDA on Apr 4, 1978, with 11 approved supplements and 0 published complete response letters.

First approved: Apr 4, 1978
Review: Standard
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE RIMSO-50 (dimethyl sulfoxide) is indicated for the symptomatic relief of patients with interstitial cystitis. RIMSO-50 has not been approved as being safe and effective for any other indication. There is no clinical evidence of effectiveness of dimethyl sulfoxide in the treatment of bacterial infections of the urinary tract.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Apr 4, 1978	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Rimso-5050% · solution;intravesical	Dimethyl Sulfoxide	RxReference drug

All 12 submissions, including labeling and manufacturing supplements


Aug 27, 2015	Supplement 23Manufacturing · Standard review	Approved	None posted
Aug 28, 2014	Supplement 22Manufacturing · Standard review	Approved	None posted
Jun 26, 2013	Supplement 21Manufacturing · Standard review	Approved	None posted
Jul 28, 2008	Supplement 19Manufacturing	Approved	None posted
May 4, 2000	Supplement 16Manufacturing · Standard review	Approved	None posted
Mar 2, 1995	Supplement 12Manufacturing · Standard review	Approved	None posted
Sep 26, 1989	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 23, 1989	Supplement 10Manufacturing · Standard review	Approved	None posted
Oct 12, 1988	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 29, 1980	Supplement 1Labeling	Approved	None posted
Sep 29, 1980	Supplement 2Labeling	Approved	None posted
Apr 4, 1978	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 17788
Drugs@FDA: Overview at FDA
Company: Mylan Institutional

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