Relieves acute nonspecific diarrhea. ANDA 216876, held by Rubicon Research. Loperamide Hydrochloride.
As of Nov 15, 2026, ANDA 216876 (Loperamide Hydrochloride), held by Rubicon Research, was first approved by FDA on Jan 26, 2023, 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 |
|---|---|---|---|
| Jan 26, 2023 | 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
