Dicyclomine Hydrochloride

Treats functional bowel/irritable bowel syndrome. ANDA 40204, held by Hikma. Dicyclomine Hydrochloride.

As of Nov 15, 2026, ANDA 40204 (Dicyclomine Hydrochloride), held by Hikma, was first approved by FDA on Feb 28, 1997, with 4 approved supplements and 0 published complete response letters.

First approved: Feb 28, 1997
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Dicyclomine hydrochloride capsules, USP are indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine hydrochloride capsules, USP are 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 5 submissions below

Date	Submission	Status	Documents
Feb 28, 1997	Original application	Approved	None posted

Products

1 strengths and forms

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

All 5 submissions, including labeling and manufacturing supplements


May 11, 2012	Supplement 5Labeling	Approved	None posted
Jan 22, 2002	Supplement 3Manufacturing	Approved	None posted
Oct 1, 1998	Supplement 2Manufacturing	Approved	None posted
Sep 17, 1997	Supplement 1Labeling	Approved	None posted
Feb 28, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 40204
Drugs@FDA: Overview at FDA
Company: Hikma

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