Treats functional bowel/irritable bowel syndrome. ANDA 40230, held by Lannett. Dicyclomine Hydrochloride.
As of Nov 15, 2026, ANDA 40230 (Dicyclomine Hydrochloride), held by Lannett, was first approved by FDA on Feb 26, 1999, with 9 approved supplements and 0 published complete response letters.
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
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 26, 1999 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dicyclomine Hydrochloride20MG · tablet;oral | Dicyclomine Hydrochloride | Rx |
| Apr 30, 2013 | Supplement 15Labeling · Standard review | Approved | None posted |
| Sep 30, 2011 | Supplement 14Labeling | Approved | None posted |
| Feb 29, 2008 | Supplement 10Labeling | Approved | None posted |
| Feb 29, 2008 | Supplement 11Labeling | Approved | None posted |
| Sep 7, 2007 | Supplement 9Labeling | Approved | None posted |
| Aug 8, 2002 | Supplement 5Manufacturing | Approved | None posted |
| Apr 18, 2001 | Supplement 4Manufacturing | Approved | None posted |
| Aug 10, 2000 | Supplement 3Manufacturing | Approved | None posted |
| Oct 21, 1999 | Supplement 2Manufacturing | Approved | None posted |
| Feb 26, 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
