Urispas

NDA 16769, held by Ortho Mcneil Janssen. Flavoxate Hydrochloride.

As of Nov 13, 2026, NDA 16769 (Urispas), held by Ortho Mcneil Janssen, was first approved by FDA on Jan 15, 1970, with 22 approved supplements and 0 published complete response letters.

First approved: Jan 15, 1970
Review: Standard
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Jan 15, 1970	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Urispas100MG · tablet;oral	Flavoxate Hydrochloride	Discontinued

All 23 submissions, including labeling and manufacturing supplements


Jan 3, 2001	Supplement 33Manufacturing · Standard review	Approved	None posted
Apr 21, 2000	Supplement 32Manufacturing · Standard review	Approved	None posted
Oct 29, 1999	Supplement 31Manufacturing · Standard review	Approved	None posted
Mar 19, 1996	Supplement 30Manufacturing · Standard review	Approved	None posted
Sep 27, 1994	Supplement 29Manufacturing · Standard review	Approved	None posted
Sep 18, 1985	Supplement 25Labeling · Standard review	Approved	None posted
Jan 4, 1984	Supplement 27Manufacturing · Standard review	Approved	None posted
Oct 8, 1982	Supplement 26Labeling · Standard review	Approved	None posted
May 29, 1979	Supplement 24Labeling · Standard review	Approved	None posted
Jan 4, 1979	Supplement 23Labeling · Standard review	Approved	None posted
May 15, 1978	Supplement 22Manufacturing · Standard review	Approved	None posted
May 15, 1978	Supplement 21Manufacturing · Standard review	Approved	None posted
Jul 13, 1977	Supplement 20Labeling · Standard review	Approved	None posted
Jul 13, 1977	Supplement 19Labeling · Standard review	Approved	None posted
Apr 27, 1977	Supplement 18Manufacturing · Standard review	Approved	None posted
Sep 24, 1976	Supplement 17Labeling · Standard review	Approved	None posted
Sep 24, 1976	Supplement 16Labeling · Standard review	Approved	None posted
Aug 10, 1976	Supplement 14Manufacturing · Standard review	Approved	None posted
Jun 18, 1976	Supplement 13Labeling · Standard review	Approved	None posted
Apr 19, 1976	Supplement 12Labeling · Standard review	Approved	None posted
Jan 9, 1976	Supplement 11Manufacturing · Standard review	Approved	None posted
Jul 25, 1975	Supplement 10Manufacturing · Standard review	Approved	None posted
Jan 15, 1970	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 16769
Drugs@FDA: Overview at FDA
Company: Ortho-McNeil-Janssen Pharmaceuticals

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