Treats functional bowel/irritable bowel syndrome. ANDA 40319, held by Aurobindo Pharma USA. Dicyclomine Hydrochloride.
As of Nov 15, 2026, ANDA 40319 (Dicyclomine Hydrochloride), held by Aurobindo Pharma USA, was first approved by FDA on Sep 7, 1999, with 5 approved supplements and 0 published complete response letters.
Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine is an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 7, 1999 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dicyclomine Hydrochloride10MG · capsule;oral | Dicyclomine Hydrochloride | Rx |
| Apr 30, 2013 | Supplement 8Labeling · Standard review | Approved | None posted |
| Dec 28, 2012 | Supplement 7Labeling · Standard review | Approved | None posted |
| Nov 30, 2007 | Supplement 3Labeling | Approved | None posted |
| Dec 12, 2002 | Supplement 2Manufacturing | Approved | None posted |
| Dec 22, 1999 | Supplement 1Labeling | Approved | None posted |
| Sep 7, 1999 | Original application | Approved |
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
