ANDA 88441, held by Odyssey Pharms. Bethanechol Chloride.
As of Nov 15, 2026, ANDA 88441 (Urecholine), held by Odyssey Pharms, was first approved by FDA on May 29, 1984, with 16 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 29, 1984 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Urecholine25MG ยท tablet;oral | Bethanechol Chloride | DiscontinuedReference drug |
| Mar 12, 2002 | Supplement 19Labeling | Approved | None posted |
| Mar 12, 2002 | Supplement 18Manufacturing | Approved | None posted |
| Oct 25, 2001 | Supplement 16Manufacturing | Approved | None posted |
| Oct 12, 2001 | Supplement 17Manufacturing | Approved | None posted |
| Oct 25, 2000 | Supplement 15Manufacturing | Approved | None posted |
| Oct 2, 2000 | Supplement 14Manufacturing | Approved | None posted |
| Aug 3, 2000 | Supplement 13Manufacturing | Approved | None posted |
| Feb 24, 2000 | Supplement 12Manufacturing | Approved | None posted |
| May 22, 1996 | Supplement 11Labeling | Approved | None posted |
| May 11, 1994 | Supplement 10Manufacturing | Approved | None posted |
| May 14, 1992 | Supplement 9Labeling | Approved | None posted |
| Feb 28, 1992 | Supplement 8Labeling | Approved | None posted |
| Aug 1, 1991 | Supplement 5Manufacturing | Approved | None posted |
| Mar 25, 1991 | Supplement 7Labeling | Approved | None posted |
| Jun 30, 1986 | Supplement 2Manufacturing | Approved | None posted |
| May 15, 1986 | Supplement 3Manufacturing | Approved | None posted |
| May 29, 1984 | Original application | Approved |
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
