ANDA 74091, held by Ohm Labs. Loperamide Hydrochloride.
As of Nov 15, 2026, ANDA 74091 (Loperamide Hydrochloride), held by Ohm Labs, was first approved by FDA on Dec 10, 1992, with 13 approved supplements and 0 published complete response letters.
Use controls symptoms of diarrhea, including Travelers' Diarrhea
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 10, 1992 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loperamide Hydrochloride2MG · tablet;oral | Loperamide Hydrochloride | OTC |
| Jul 9, 2021 | Supplement 30Labeling · Standard review | Approved | None posted |
| Jul 9, 2021 | Supplement 33Labeling · Standard review | Approved | None posted |
| Jul 9, 2021 | Supplement 34Labeling · Standard review | Approved | None posted |
| Sep 9, 2020 | Supplement 36Labeling · Standard review | Approved | None posted |
| Sep 12, 2006 | Supplement 21Labeling | Approved | None posted |
| Oct 16, 2002 | Supplement 9Labeling | Approved | None posted |
| Jan 17, 2002 | Supplement 8Manufacturing | Approved | None posted |
| Dec 28, 2000 | Supplement 5Labeling | Approved | None posted |
| Jun 21, 2000 | Supplement 7Manufacturing | Approved | None posted |
| Feb 27, 1998 | Supplement 3Labeling | Approved | None posted |
| May 13, 1997 | Supplement 4Manufacturing | Approved | None posted |
| Jul 18, 1994 | Supplement 2Manufacturing | Approved | None posted |
| Jun 16, 1993 | Supplement 1Labeling | Approved | None posted |
| Dec 10, 1992 | 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
