Urecholine

NDA 6536, held by Teva Branded Pharm. Bethanechol Chloride.

As of Nov 13, 2026, NDA 6536 (Urecholine), held by Teva Branded Pharm, was first approved by FDA on Oct 12, 1948, with 31 approved supplements and 0 published complete response letters.

First approved: Oct 12, 1948
Supplements approved: 31
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 32 submissions below

Date	Submission	Status	Documents
Oct 12, 1948	Original application	Approved	None posted

Products

5 strengths and forms


Urecholine5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Bethanechol Chloride	DiscontinuedReference drug
Urecholine10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Bethanechol Chloride	DiscontinuedReference drug
Urecholine5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Bethanechol Chloride	DiscontinuedReference drug
Urecholine25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Bethanechol Chloride	DiscontinuedReference drug
Urecholine50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Bethanechol Chloride	DiscontinuedReference drug

All 32 submissions, including labeling and manufacturing supplements


Apr 2, 1998	Supplement 38Labeling · Standard review	Approved	None posted
Mar 31, 1998	Supplement 42Manufacturing	Approved	None posted
Jan 20, 1998	Supplement 43Manufacturing	Approved	None posted
Aug 14, 1997	Supplement 41Manufacturing	Approved	None posted
Sep 3, 1996	Supplement 40Manufacturing	Approved	None posted
Mar 11, 1996	Supplement 39Manufacturing	Approved	None posted
Sep 11, 1995	Supplement 37Manufacturing	Approved	None posted
Aug 9, 1993	Supplement 36Labeling	Approved	None posted
Aug 28, 1992	Supplement 35Manufacturing	Approved	None posted
Mar 9, 1987	Supplement 34Labeling	Approved	None posted
Sep 12, 1985	Supplement 33Manufacturing	Approved	None posted
Jul 3, 1985	Supplement 32Manufacturing	Approved	None posted
Jan 14, 1985	Supplement 28Labeling	Approved	None posted
Oct 24, 1984	Supplement 30Manufacturing	Approved	None posted
Oct 11, 1984	Supplement 31Manufacturing	Approved	None posted
Sep 16, 1983	Supplement 29Manufacturing	Approved	None posted
Nov 3, 1981	Supplement 26Manufacturing	Approved	None posted
Jul 14, 1981	Supplement 27Manufacturing	Approved	None posted
Jun 17, 1981	Supplement 25Manufacturing	Approved	None posted
Dec 22, 1980	Supplement 24Manufacturing	Approved	None posted
Jun 24, 1980	Supplement 21Labeling	Approved	None posted
May 29, 1980	Supplement 22Manufacturing	Approved	None posted
May 1, 1980	Supplement 23Labeling	Approved	None posted
May 1, 1980	Supplement 18Labeling	Approved	None posted
May 1, 1980	Supplement 17Labeling	Approved	None posted
Aug 13, 1979	Supplement 20Labeling	Approved	None posted
Oct 2, 1978	Supplement 16Labeling	Approved	None posted
Dec 12, 1977	Supplement 15Manufacturing	Approved	None posted
Sep 19, 1977	Supplement 14Labeling	Approved	None posted
May 17, 1976	Supplement 13Labeling	Approved	None posted
May 17, 1976	Supplement 12Manufacturing	Approved	None posted
Oct 12, 1948	Original application	Approved	None posted

Identifiers

Application: NDA 6536
Drugs@FDA: Overview at FDA
Company: Teva Branded Pharmaceutical Products

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