Relieves acute nonspecific diarrhea. ANDA 215579, held by Bionpharma. Loperamide Hydrochloride.
As of Nov 15, 2026, ANDA 215579 (Loperamide Hydrochloride), held by Bionpharma, was first approved by FDA on Oct 22, 2021, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Loperamide hydrochloride capsules are indicated for the control and symptomatic relief of acute nonspecific diarrhea in patients 2 years of age and older and of chronic diarrhea in adults associated with inflammatory bowel disease. Loperamide hydrochloride capsules are also indicated for reducing the volume of discharge from ileostomies.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 22, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loperamide Hydrochloride2MG · 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
