ANDA 220372, held by Aurobindo Pharma. Loperamide Hydrochloride.
As of Nov 15, 2026, ANDA 220372 (Loperamide Hydrochloride), held by Aurobindo Pharma, was first approved by FDA on Dec 29, 2025, with 0 approved supplements and 0 published complete response letters.
Use controls symptoms of diarrhea, including Travelers' Diarrhea
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 29, 2025 | Original application | Approved | None posted |
| 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
