Urecholine

ANDA 89095, held by Odyssey Pharms. Bethanechol Chloride.

As of Nov 15, 2026, ANDA 89095 (Urecholine), held by Odyssey Pharms, was first approved by FDA on Dec 19, 1985, with 12 approved supplements and 0 published complete response letters.

First approved: Dec 19, 1985
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Dec 19, 1985	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Urecholine5MG · tablet;oral	Bethanechol Chloride	Discontinued

All 13 submissions, including labeling and manufacturing supplements


Oct 25, 2001	Supplement 12Manufacturing	Approved	None posted
Oct 12, 2001	Supplement 13Manufacturing	Approved	None posted
Jul 20, 2001	Supplement 14Manufacturing	Approved	None posted
Oct 25, 2000	Supplement 11Manufacturing	Approved	None posted
Oct 2, 2000	Supplement 10Manufacturing	Approved	None posted
May 22, 1996	Supplement 9Labeling	Approved	None posted
May 11, 1994	Supplement 8Manufacturing	Approved	None posted
May 14, 1992	Supplement 7Labeling	Approved	None posted
Mar 31, 1992	Supplement 3Manufacturing	Approved	None posted
Feb 28, 1992	Supplement 6Labeling	Approved	None posted
Mar 25, 1991	Supplement 5Labeling	Approved	None posted
Jul 30, 1986	Supplement 1Manufacturing	Approved	None posted
Dec 19, 1985	Original application	Approved	Review

Identifiers

Application: ANDA 89095
Drugs@FDA: Overview at FDA
Company: Odyssey 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