Treats functional bowel/irritable bowel syndrome. ANDA 217916, held by Bionpharma. Dicyclomine Hydrochloride.
As of Nov 15, 2026, ANDA 217916 (Dicyclomine Hydrochloride), held by Bionpharma, was first approved by FDA on Aug 4, 2023, with 0 approved supplements and 0 published complete response letters.
Dicyclomine hydrochloride tablets are 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 4, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dicyclomine Hydrochloride20MG · tablet;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
