Dicyclomine Hydrochloride

Treats functional bowel/irritable bowel syndrome. ANDA 85082, held by Watson Labs. Dicyclomine Hydrochloride.

As of Nov 15, 2026, ANDA 85082 (Dicyclomine Hydrochloride), held by Watson Labs, was first approved by FDA on Jul 28, 1976, with 22 approved supplements and 0 published complete response letters.

First approved: Jul 28, 1976
Supplements approved: 22
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 ( Error! Hyperlink reference not valid. )

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Jul 28, 1976	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dicyclomine Hydrochloride10MG · capsule;oral	Dicyclomine Hydrochloride	Rx

All 23 submissions, including labeling and manufacturing supplements


Nov 27, 2013	Supplement 38Labeling · Standard review	Approved	None posted
Aug 13, 2013	Supplement 37Labeling · Standard review	Approved	None posted
Dec 31, 2012	Supplement 36Labeling · Standard review	Approved	None posted
Jul 23, 1997	Supplement 34Manufacturing	Approved	None posted
Jul 23, 1997	Supplement 33Manufacturing	Approved	None posted
Jul 23, 1997	Supplement 32Manufacturing	Approved	None posted
Mar 12, 1991	Supplement 31Labeling	Approved	None posted
Aug 23, 1990	Supplement 30Labeling	Approved	None posted
Mar 15, 1990	Supplement 29Labeling	Approved	None posted
Feb 2, 1989	Supplement 28Manufacturing	Approved	None posted
Feb 2, 1989	Supplement 27Manufacturing	Approved	None posted
Aug 15, 1988	Supplement 25Manufacturing	Approved	None posted
Jan 22, 1988	Supplement 24Manufacturing	Approved	None posted
Jan 22, 1988	Supplement 23Manufacturing	Approved	None posted
May 20, 1986	Supplement 21Manufacturing	Approved	None posted
Mar 4, 1986	Supplement 20Manufacturing	Approved	None posted
Jun 21, 1983	Supplement 15Manufacturing	Approved	None posted
Apr 25, 1983	Supplement 14Manufacturing	Approved	None posted
Apr 25, 1983	Supplement 13Manufacturing	Approved	None posted
Mar 10, 1983	Supplement 12Manufacturing	Approved	None posted
Mar 10, 1983	Supplement 11Manufacturing	Approved	None posted
Feb 10, 1982	Supplement 10Manufacturing	Approved	None posted
Jul 28, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 85082
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