ANDA 217840, held by Jubilant Cadista. Loperamide Hydrochloride.
As of Nov 15, 2026, ANDA 217840 (Loperamide Hydrochloride), held by Jubilant Cadista, was first approved by FDA on Jul 5, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 5, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loperamide Hydrochloride2MG ยท capsule;oral | Loperamide Hydrochloride | Rx |
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
