Bethanechol Chloride

ANDA 84441, held by Watson Labs. Bethanechol Chloride.

As of Nov 15, 2026, ANDA 84441 (Bethanechol Chloride), held by Watson Labs, was first approved by FDA on Jan 14, 1975, with 13 approved supplements and 0 published complete response letters.

First approved: Jan 14, 1975
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Jan 14, 1975	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Bethanechol Chloride25MG · tablet;oral	Bethanechol Chloride	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Apr 18, 1996	Supplement 46Labeling	Approved	None posted
May 31, 1991	Supplement 43Manufacturing	Approved	None posted
Mar 22, 1991	Supplement 45Labeling	Approved	None posted
Jan 28, 1991	Supplement 44Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 42Manufacturing	Approved	None posted
Mar 16, 1988	Supplement 41Manufacturing	Approved	None posted
Mar 16, 1988	Supplement 40Manufacturing	Approved	None posted
Mar 16, 1988	Supplement 39Manufacturing	Approved	None posted
Aug 11, 1987	Supplement 37Manufacturing	Approved	None posted
Jul 19, 1985	Supplement 34Manufacturing	Approved	None posted
Mar 8, 1984	Supplement 33Manufacturing	Approved	None posted
Aug 2, 1983	Supplement 30Manufacturing	Approved	None posted
Apr 12, 1982	Supplement 25Manufacturing	Approved	None posted
Jan 14, 1975	Original application	Approved	None posted

Identifiers

Application: ANDA 84441
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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