Treats functional bowel/irritable bowel syndrome. ANDA 208353, held by Am Regent. Dicyclomine Hydrochloride.
As of Nov 15, 2026, ANDA 208353 (Dicyclomine Hydrochloride), held by Am Regent, was first approved by FDA on Feb 17, 2017, 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, USP is an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 17, 2017 | 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
