ANDA 219767, held by Rising. Tamsulosin Hydrochloride.
As of Nov 15, 2026, ANDA 219767 (Tamsulosin Hydrochloride), held by Rising, was first approved by FDA on May 1, 2025, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 1, 2025 | 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