Bethanechol Chloride

ANDA 84402, held by Watson Labs. Bethanechol Chloride.

As of Nov 15, 2026, ANDA 84402 (Bethanechol Chloride), held by Watson Labs, was first approved by FDA on Nov 26, 1974, with 3 approved supplements and 0 published complete response letters.

First approved: Nov 26, 1974
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Nov 26, 1974	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Bethanechol Chloride5MG · tablet;oral	Bethanechol Chloride	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Apr 18, 1996	Supplement 30Labeling	Approved	None posted
Mar 22, 1991	Supplement 29Labeling	Approved	None posted
Mar 10, 1988	Supplement 22Labeling	Approved	None posted
Nov 26, 1974	Original application	Approved	None posted

Identifiers

Application: ANDA 84402
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