Treats functional bowel/irritable bowel syndrome. ANDA 217531, held by Prinston. Dicyclomine Hydrochloride.
As of Nov 15, 2026, ANDA 217531 (Dicyclomine Hydrochloride), held by Prinston, was first approved by FDA on Aug 30, 2023, with 0 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 |
|---|---|---|---|
| Aug 30, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dicyclomine Hydrochloride10MG · capsule;oral | Dicyclomine Hydrochloride | Rx |
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
