Treats functional bowel/irritable bowel syndrome. ANDA 217566, held by Annora Pharma. Dicyclomine Hydrochloride.
As of Nov 15, 2026, ANDA 217566 (Dicyclomine Hydrochloride), held by Annora Pharma, was first approved by FDA on May 7, 2024, with 0 approved supplements and 0 published complete response letters.
Dicyclomine hydrochloride tablets are indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine hydrochloride tablets are an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 7, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dicyclomine Hydrochloride20MG · tablet;oral | 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
