ANDA 74991, held by Duramed Pharms Barr. Loperamide Hydrochloride.
As of Nov 15, 2026, ANDA 74991 (Loperamide Hydrochloride), held by Duramed Pharms Barr, was first approved by FDA on Dec 29, 1997, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 29, 1997 | 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
