ANDA 73122, held by Teva. Loperamide Hydrochloride.
As of Nov 15, 2026, ANDA 73122 (Loperamide Hydrochloride), held by Teva, was first approved by FDA on Aug 30, 1991, with 16 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 30, 1991 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loperamide Hydrochloride2MG · capsule;oral | Loperamide Hydrochloride | Discontinued |
| Dec 5, 2016 | Supplement 19Labeling · Standard review | Approved | None posted |
| Sep 18, 2000 | Supplement 18Manufacturing | Approved | None posted |
| Aug 16, 1999 | Supplement 16Manufacturing | Approved | None posted |
| Dec 9, 1998 | Supplement 15Manufacturing | Approved | None posted |
| Mar 17, 1998 | Supplement 14Manufacturing | Approved | None posted |
| Dec 27, 1996 | Supplement 12Manufacturing | Approved | None posted |
| Dec 27, 1996 | Supplement 10Labeling | Approved | None posted |
| Dec 27, 1996 | Supplement 9Manufacturing | Approved | None posted |
| Aug 28, 1996 | Supplement 13Manufacturing | Approved | None posted |
| Jul 18, 1994 | Supplement 8Manufacturing | Approved | None posted |
| May 27, 1994 | Supplement 5Manufacturing | Approved | None posted |
| Mar 16, 1994 | Supplement 7Manufacturing | Approved | None posted |
| Mar 16, 1994 | Supplement 6Manufacturing | Approved | None posted |
| Dec 2, 1993 | Supplement 3Manufacturing | Approved | None posted |
| Aug 20, 1993 | Supplement 2Manufacturing | Approved | None posted |
| Aug 20, 1993 | Supplement 1Manufacturing | Approved | None posted |
| Aug 30, 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
