Urecholine

ANDA 88440, held by Odyssey Pharms. Bethanechol Chloride.

As of Nov 15, 2026, ANDA 88440 (Urecholine), held by Odyssey Pharms, was first approved by FDA on May 29, 1984, with 14 approved supplements and 0 published complete response letters.

First approved: May 29, 1984
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
May 29, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Urecholine10MG · tablet;oral	Bethanechol Chloride	DiscontinuedReference drug

All 15 submissions, including labeling and manufacturing supplements


Mar 12, 2002	Supplement 15Manufacturing	Approved	None posted
Mar 12, 2002	Supplement 16Labeling	Approved	None posted
Oct 25, 2001	Supplement 13Manufacturing	Approved	None posted
Oct 12, 2001	Supplement 14Manufacturing	Approved	None posted
Oct 25, 2000	Supplement 12Manufacturing	Approved	None posted
Oct 2, 2000	Supplement 11Manufacturing	Approved	None posted
May 22, 1996	Supplement 10Labeling	Approved	None posted
May 11, 1994	Supplement 9Manufacturing	Approved	None posted
May 14, 1992	Supplement 8Labeling	Approved	None posted
Feb 28, 1992	Supplement 7Labeling	Approved	None posted
Mar 25, 1991	Supplement 6Labeling	Approved	None posted
Jul 8, 1988	Supplement 5Manufacturing	Approved	None posted
Jun 30, 1986	Supplement 2Manufacturing	Approved	None posted
May 15, 1986	Supplement 3Manufacturing	Approved	None posted
May 29, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 88440
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