Dicyclomine Hydrochloride (Preservative Free)

Treats functional bowel/irritable bowel syndrome. ANDA 40465, held by Hikma. Dicyclomine Hydrochloride.

As of Nov 15, 2026, ANDA 40465 (Dicyclomine Hydrochloride (Preservative Free)), held by Hikma, was first approved by FDA on Jun 30, 2003, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 30, 2003
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Dicyclomine Hydrochloride Injection, USP is indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine Hydrochloride Injection, USP 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 5 submissions below

Date	Submission	Status	Documents
Jun 30, 2003	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dicyclomine Hydrochloride (Preservative Free)10MG/ML · injectable;injection	Dicyclomine Hydrochloride	Rx

All 5 submissions, including labeling and manufacturing supplements


May 29, 2018	Supplement 7Labeling · Standard review	Approved	None posted
May 29, 2018	Supplement 8Labeling · Standard review	Approved	None posted
May 10, 2012	Supplement 5Labeling	Approved	None posted
Oct 5, 2007	Supplement 2Labeling	Approved	None posted
Jun 30, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 40465
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