ANDA 213070, held by Onesource. Loperamide Hydrochloride.
As of Nov 15, 2026, ANDA 213070 (Loperamide Hydrochloride), held by Onesource, was first approved by FDA on Aug 11, 2021, with 0 approved supplements and 0 published complete response letters.
Use controls symptoms of diarrhea, including Travelers' Diarrhea
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 11, 2021 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loperamide Hydrochloride2MG · 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
