Treats functional bowel/irritable bowel syndrome. ANDA 216736, held by Rubicon Research. Dicyclomine Hydrochloride.
As of Nov 15, 2026, ANDA 216736 (Dicyclomine Hydrochloride), held by Rubicon Research, was first approved by FDA on Dec 14, 2022, with 1 approved supplement 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 |
|---|---|---|---|
| Dec 14, 2022 | Original application | Approved | None posted |
| Dicyclomine Hydrochloride20MG · tablet;oral | Dicyclomine Hydrochloride | Rx |
| Dicyclomine Hydrochloride40MG · tablet;oral | Dicyclomine Hydrochloride | Rx |
| Sep 15, 2025 | Supplement 3Manufacturing | Approved | None posted |
| Dec 14, 2022 | 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
