ANDA 75232, held by L Perrigo Co. Loperamide Hydrochloride.
As of Nov 15, 2026, ANDA 75232 (Loperamide Hydrochloride), held by L Perrigo Co, was first approved by FDA on Jan 6, 2000, with 9 approved supplements and 0 published complete response letters.
Use controls symptoms of diarrhea, including Travelers' Diarrhea
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 6, 2000 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loperamide Hydrochloride2MG · tablet;oral | Loperamide Hydrochloride | OTC |
| Jun 8, 2020 | Supplement 44Labeling · Standard review | Approved | None posted |
| Jun 8, 2020 | Supplement 46Labeling · Standard review | Approved | None posted |
| Oct 23, 2007 | Supplement 20Labeling | Approved | None posted |
| Oct 4, 2002 | Supplement 1Manufacturing | Approved | None posted |
| Oct 4, 2002 | Supplement 2Manufacturing | Approved | None posted |
| Oct 4, 2002 | Supplement 3Manufacturing | Approved | None posted |
| Oct 4, 2002 | Supplement 4Labeling | Approved | None posted |
| Oct 4, 2002 | Supplement 5Manufacturing | Approved | None posted |
| Oct 4, 2002 | Supplement 6Labeling | Approved | None posted |
| Jan 6, 2000 | Original application | Approved |
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
