NDA 21855, held by Bionpharma. Loperamide Hydrochloride.
As of Nov 14, 2026, NDA 21855 (Loperamide Hydrochloride), held by Bionpharma, was first approved by FDA on Aug 4, 2005, with 4 approved supplements and 0 published complete response letters.
Use controls symptoms of diarrhea, including Travelers' Diarrhea
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 4, 2005 | Original applicationNew dosage form · Standard review | Approved |
| Loperamide Hydrochloride1MG · capsule;oral | Loperamide Hydrochloride | OTCReference drug |
| Loperamide Hydrochloride2MG · capsule;oral | Loperamide Hydrochloride | OTCReference drug |
| Jun 22, 2020 | Supplement 14Labeling · Standard review | Approved | |
| Jan 31, 2019 | Supplement 9Manufacturing | Approved | |
| Mar 9, 2017 | Supplement 6Labeling · Standard review | Approved | |
| Dec 11, 2015 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Aug 4, 2005 | Original applicationNew dosage form · Standard review | 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
