Bethanechol Chloride

ANDA 84353, held by Sandoz. Bethanechol Chloride.

As of Nov 15, 2026, ANDA 84353 (Bethanechol Chloride), held by Sandoz, was first approved by FDA on Sep 16, 1994, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 16, 1994
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Sep 16, 1994	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Sep 16, 1994	Original application	Approved	None posted
Mar 26, 1986	Supplement 5Manufacturing	Approved	None posted
Nov 4, 1982	Supplement 4Manufacturing	Approved	None posted

Identifiers

Application: ANDA 84353
Drugs@FDA: Overview at FDA
Company: Sandoz

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