Duvoid

ANDA 86263, held by Chartwell Rx. Bethanechol Chloride.

As of Nov 15, 2026, ANDA 86263 (Duvoid), held by Chartwell Rx, was first approved by FDA on Mar 22, 1978, with 5 approved supplements and 0 published complete response letters.

First approved: Mar 22, 1978
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Mar 22, 1978	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Duvoid25MG · tablet;oral	Bethanechol Chloride	Rx

All 6 submissions, including labeling and manufacturing supplements


Jun 28, 2004	Supplement 22Labeling	Approved	None posted
Jul 11, 1996	Supplement 15Labeling	Approved	None posted
Dec 28, 1989	Supplement 14Labeling	Approved	None posted
Nov 15, 1988	Supplement 13Labeling	Approved	None posted
Sep 29, 1983	Supplement 11Manufacturing	Approved	None posted
Mar 22, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 86263
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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