Treats functional bowel/irritable bowel syndrome. ANDA 207076, held by Slate Run Pharma. Dicyclomine Hydrochloride.
As of Nov 15, 2026, ANDA 207076 (Dicyclomine Hydrochloride), held by Slate Run Pharma, was first approved by FDA on Nov 2, 2018, 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 |
|---|---|---|---|
| Nov 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
