Relieves acute nonspecific diarrhea. ANDA 72741, held by Mylan. Loperamide Hydrochloride.
As of Nov 15, 2026, ANDA 72741 (Loperamide Hydrochloride), held by Mylan, was first approved by FDA on Sep 18, 1991, with 7 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 |
|---|---|---|---|
| Sep 18, 1991 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loperamide Hydrochloride2MG · capsule;oral | Loperamide Hydrochloride | Rx |
| Nov 3, 2016 | Supplement 13Labeling · Standard review | Approved | None posted |
| Jun 25, 2007 | Supplement 8Labeling | Approved | None posted |
| Aug 2, 2000 | Supplement 6Manufacturing | Approved | None posted |
| Apr 6, 1998 | Supplement 3Manufacturing | Approved | None posted |
| Apr 6, 1998 | Supplement 5Manufacturing | Approved | None posted |
| Feb 5, 1998 | Supplement 4Manufacturing | Approved | None posted |
| Apr 18, 1996 | Supplement 2Labeling | Approved | None posted |
| Sep 18, 1991 | Original application | Approved | None posted |
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
