Bethanechol Chloride

ANDA 84702, held by Lannett. Bethanechol Chloride.

As of Nov 15, 2026, ANDA 84702 (Bethanechol Chloride), held by Lannett, was first approved by FDA on Jun 16, 1976, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 16, 1976
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jun 16, 1976	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Nov 1, 1988	Supplement 70Manufacturing	Approved	None posted
Jun 16, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 84702
Drugs@FDA: Overview at FDA
Company: Lannett Company

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