Treats functional bowel/irritable bowel syndrome. ANDA 214332, held by Somerset Theraps LLC. Dicyclomine Hydrochloride.
As of Nov 15, 2026, ANDA 214332 (Dicyclomine Hydrochloride), held by Somerset Theraps LLC, was first approved by FDA on Nov 1, 2024, with 0 approved supplements and 0 published complete response letters.
Dicyclomine hydrochloride injection, USP is indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine hydrochloride injection is an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 1, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dicyclomine Hydrochloride10MG/ML · injectable;injection | 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
