ANDA 220153, held by Pharmazone. Loperamide Hydrochloride.
As of Nov 15, 2026, ANDA 220153 (Loperamide Hydrochloride), held by Pharmazone, was first approved by FDA on Nov 17, 2025, with 0 approved supplements and 0 published complete response letters.
Use controls symptoms of diarrhea, including Travelers' Diarrhea
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 17, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loperamide Hydrochloride2MG · tablet;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
