Treats functional bowel/irritable bowel syndrome. ANDA 210257, held by Fresenius Kabi USA. Dicyclomine Hydrochloride.
As of Nov 15, 2026, ANDA 210257 (Dicyclomine Hydrochloride), held by Fresenius Kabi USA, was first approved by FDA on Jan 25, 2019, with 0 approved supplements and 0 published complete response letters.
Dicyclomine hydrochloride is 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 |
|---|---|---|---|
| Jan 25, 2019 | 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
