ANDA 73187, held by Alpharma US Pharms. Loperamide Hydrochloride.
As of Nov 15, 2026, ANDA 73187 (Loperamide Hydrochloride), held by Alpharma US Pharms, was first approved by FDA on Sep 15, 1992, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 15, 1992 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loperamide Hydrochloride1MG/5ML ยท solution;oral | Loperamide Hydrochloride | 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
