Treats functional bowel/irritable bowel syndrome. ANDA 210979, held by Fosun Pharma. Dicyclomine Hydrochloride.
As of Nov 15, 2026, ANDA 210979 (Dicyclomine Hydrochloride), held by Fosun Pharma, was first approved by FDA on Jul 2, 2018, with 0 approved supplements and 0 published complete response letters.
Dicyclomine hydrochloride injection 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 |
|---|---|---|---|
| Jul 2, 2018 | 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
