ANDA 211885, held by Chartwell Rx. Tamsulosin Hydrochloride.
As of Nov 15, 2026, ANDA 211885 (Tamsulosin Hydrochloride), held by Chartwell Rx, was first approved by FDA on Oct 17, 2019, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 17, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tamsulosin Hydrochloride0.4MG ยท capsule;oral | Tamsulosin 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