ANDA 220722, held by Taro. Loperamide Hydrochloride.
As of Nov 15, 2026, ANDA 220722 (Loperamide Hydrochloride), held by Taro, was first approved by FDA on Sep 30, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 30, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loperamide Hydrochloride2MG ยท capsule;oral | Loperamide Hydrochloride | OTC |
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
