Treats functional bowel/irritable bowel syndrome. ANDA 219242, held by Rising. Dicyclomine Hydrochloride.
As of Nov 15, 2026, ANDA 219242 (Dicyclomine Hydrochloride), held by Rising, was first approved by FDA on Jun 23, 2025, 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 capsules are an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 23, 2025 | 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
