Treats functional bowel/irritable bowel syndrome. ANDA 216515, held by Rubicon Research. Dicyclomine Hydrochloride.
As of Nov 15, 2026, ANDA 216515 (Dicyclomine Hydrochloride), held by Rubicon Research, was first approved by FDA on Jul 17, 2026, with 0 approved supplements and 0 published complete response letters.
Dicyclomine hydrochloride capsules 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 |
|---|---|---|---|
| Jul 17, 2026 | 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
