Relieves acute nonspecific diarrhea. ANDA 217471, held by Zydus Lifesciences. Loperamide Hydrochloride.
As of Nov 15, 2026, ANDA 217471 (Loperamide Hydrochloride), held by Zydus Lifesciences, was first approved by FDA on Mar 23, 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 |
|---|---|---|---|
| Mar 23, 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
