Dicyclomine Hydrochloride

Treats functional bowel/irritable bowel syndrome. ANDA 85223, held by Watson Labs. Dicyclomine Hydrochloride.

As of Nov 15, 2026, ANDA 85223 (Dicyclomine Hydrochloride), held by Watson Labs, was first approved by FDA on Aug 17, 1976, with 23 approved supplements and 0 published complete response letters.

First approved: Aug 17, 1976
Supplements approved: 23
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Aug 17, 1976	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dicyclomine Hydrochloride20MG · tablet;oral	Dicyclomine Hydrochloride	Rx

All 24 submissions, including labeling and manufacturing supplements


Nov 27, 2013	Supplement 44Labeling · Standard review	Approved	None posted
Aug 13, 2013	Supplement 43Labeling · Standard review	Approved	None posted
Dec 31, 2012	Supplement 42Labeling · Standard review	Approved	None posted
Mar 25, 1998	Supplement 39Labeling	Approved	None posted
Jul 16, 1997	Supplement 38Manufacturing	Approved	None posted
Jul 16, 1997	Supplement 37Manufacturing	Approved	None posted
Jan 19, 1996	Supplement 36Manufacturing	Approved	None posted
Jan 19, 1996	Supplement 35Manufacturing	Approved	None posted
Jan 19, 1996	Supplement 34Manufacturing	Approved	None posted
May 26, 1995	Supplement 33Manufacturing	Approved	None posted
Jul 11, 1994	Supplement 32Manufacturing	Approved	None posted
Mar 12, 1991	Supplement 31Labeling	Approved	None posted
Aug 23, 1990	Supplement 26Labeling	Approved	None posted
Mar 15, 1990	Supplement 25Labeling	Approved	None posted
Mar 31, 1989	Supplement 23Manufacturing	Approved	None posted
Mar 31, 1989	Supplement 22Manufacturing	Approved	None posted
Aug 15, 1988	Supplement 21Manufacturing	Approved	None posted
Jul 30, 1986	Supplement 19Manufacturing	Approved	None posted
Mar 4, 1986	Supplement 18Manufacturing	Approved	None posted
Dec 6, 1982	Supplement 12Manufacturing	Approved	None posted
Dec 6, 1982	Supplement 11Manufacturing	Approved	None posted
May 13, 1982	Supplement 10Manufacturing	Approved	None posted
Sep 26, 1979	Supplement 4Manufacturing	Approved	None posted
Aug 17, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 85223
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