ANDA 207084, held by Renew Pharms. Dicyclomine Hydrochloride.
As of Nov 15, 2026, ANDA 207084 (Dicyclomine Hydrochloride), held by Renew Pharms, was first approved by FDA on May 4, 2018, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 4, 2018 | 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
