Relieves acute nonspecific diarrhea. ANDA 215001, held by Edenbridge Pharms. Loperamide Hydrochloride.
As of Nov 15, 2026, ANDA 215001 (Loperamide Hydrochloride), held by Edenbridge Pharms, was first approved by FDA on Oct 6, 2021, with 0 approved supplements and 0 published complete response letters.
INDICATIONS & USAGE Loperamide Hydrochloride Capsules (loperamide hydrochloride) is 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 is also indicated for reducing the volume of discharge from ileostomies.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 6, 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
