Bethanechol Chloride

ANDA 87444, held by Watson Labs. Bethanechol Chloride.

As of Nov 15, 2026, ANDA 87444 (Bethanechol Chloride), held by Watson Labs, was first approved by FDA on Jul 16, 1981, with 7 approved supplements and 0 published complete response letters.

First approved: Jul 16, 1981
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jul 16, 1981	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Bethanechol Chloride50MG · tablet;oral	Bethanechol Chloride	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Nov 7, 1997	Supplement 15Manufacturing	Approved	None posted
Apr 18, 1996	Supplement 14Labeling	Approved	None posted
May 31, 1991	Supplement 11Manufacturing	Approved	None posted
Mar 22, 1991	Supplement 13Labeling	Approved	None posted
Jan 28, 1991	Supplement 12Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 10Manufacturing	Approved	None posted
Jan 29, 1988	Supplement 9Manufacturing	Approved	None posted
Jul 16, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 87444
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