Treats functional bowel/irritable bowel syndrome. ANDA 40169, held by Ph Health. Dicyclomine Hydrochloride.
As of Nov 15, 2026, ANDA 40169 (Dicyclomine Hydrochloride), held by Ph Health, was first approved by FDA on Mar 24, 2005, with 2 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 |
|---|---|---|---|
| Mar 24, 2005 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dicyclomine Hydrochloride10MG/5ML · syrup;oral | Dicyclomine Hydrochloride | Rx |
| Dec 27, 2017 | Supplement 4Labeling · Standard review | Approved | None posted |
| Aug 28, 2008 | Supplement 2Labeling | Approved | None posted |
| Mar 24, 2005 | 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
