ANDA 78938, held by Sciegen Pharms. Tamsulosin Hydrochloride.
As of Nov 15, 2026, ANDA 78938 (Tamsulosin Hydrochloride), held by Sciegen Pharms, was first approved by FDA on Apr 27, 2010, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 27, 2010 | 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
