ANDA 74730, held by Wockhardt Bio AG. Loperamide Hydrochloride.
As of Nov 15, 2026, ANDA 74730 (Loperamide Hydrochloride), held by Wockhardt Bio AG, was first approved by FDA on Aug 28, 1997, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 28, 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
