Treats functional bowel/irritable bowel syndrome. ANDA 84285, held by Lannett. Dicyclomine Hydrochloride.
As of Nov 15, 2026, ANDA 84285 (Dicyclomine Hydrochloride), held by Lannett, was first approved by FDA on Sep 30, 1974, with 11 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 ( Error! Hyperlink reference not valid. )
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 30, 1974 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dicyclomine Hydrochloride10MG · capsule;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 12Labeling | Approved | None posted |
| Feb 29, 2008 | Supplement 13Labeling | Approved | None posted |
| Sep 7, 2007 | Supplement 11Labeling | Approved | None posted |
| Aug 10, 2000 | Supplement 8Manufacturing | Approved | None posted |
| Aug 7, 1998 | Supplement 7Manufacturing | Approved | None posted |
| Mar 25, 1998 | Supplement 6Labeling | Approved | None posted |
| Oct 3, 1996 | Supplement 4Labeling | Approved | None posted |
| Apr 17, 1996 | Supplement 3Labeling | Approved | None posted |
| Mar 15, 1996 | Supplement 2Manufacturing | Approved | None posted |
| Sep 30, 1974 | Original application | Approved | None posted |
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
