ANDA 218232, held by Zydus Lifesciences. Finasteride; Tadalafil.
As of Nov 15, 2026, ANDA 218232 (Finasteride And Tadalafil), held by Zydus Lifesciences, was first approved by FDA on Mar 15, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 15, 2024 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Finasteride And Tadalafil5MG;5MG ยท capsule;oral | Finasteride; Tadalafil | 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