Bethanechol Chloride

ANDA 84408, held by Watson Labs. Bethanechol Chloride.

As of Nov 15, 2026, ANDA 84408 (Bethanechol Chloride), held by Watson Labs, was first approved by FDA on Nov 11, 1974, with 11 approved supplements and 0 published complete response letters.

First approved: Nov 11, 1974
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Nov 11, 1974	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Bethanechol Chloride10MG · tablet;oral	Bethanechol Chloride	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Apr 18, 1996	Supplement 42Labeling	Approved	None posted
May 31, 1991	Supplement 39Manufacturing	Approved	None posted
Mar 22, 1991	Supplement 41Labeling	Approved	None posted
Jan 28, 1991	Supplement 40Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 38Manufacturing	Approved	None posted
Mar 7, 1988	Supplement 37Manufacturing	Approved	None posted
Mar 7, 1988	Supplement 36Manufacturing	Approved	None posted
Mar 7, 1988	Supplement 35Manufacturing	Approved	None posted
Aug 11, 1987	Supplement 33Manufacturing	Approved	None posted
Jul 19, 1985	Supplement 31Manufacturing	Approved	None posted
Jan 7, 1982	Supplement 25Manufacturing	Approved	None posted
Nov 11, 1974	Original application	Approved	None posted

Identifiers

Application: ANDA 84408
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