ANDA 212058, held by Quagen. Dicyclomine Hydrochloride.
As of Nov 15, 2026, ANDA 212058 (Dicyclomine Hydrochloride), held by Quagen, was first approved by FDA on Apr 26, 2019, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 26, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dicyclomine Hydrochloride10MG/ML ยท injectable;injection | Dicyclomine Hydrochloride | Discontinued |
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
