ANDA 218310, held by Prinston. Dicyclomine Hydrochloride.
As of Nov 15, 2026, ANDA 218310 (Dicyclomine Hydrochloride), held by Prinston, was first approved by FDA on Jun 6, 2025, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 6, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dicyclomine Hydrochloride20MG ยท 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
