ANDA 88873, held by Pharmobedient. Edrophonium Chloride.
As of Nov 15, 2026, ANDA 88873 (Enlon), held by Pharmobedient, was first approved by FDA on Aug 6, 1985, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 6, 1985 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Enlon10MG/ML ยท injectable;injection | Edrophonium Chloride | Discontinued |
| Jan 10, 2011 | Supplement 23Manufacturing | Approved | None posted |
| Sep 28, 2009 | Supplement 22Labeling | Approved | None posted |
| Apr 3, 2009 | Supplement 19Labeling | Approved | None posted |
| Feb 20, 2001 | Supplement 16Manufacturing | Approved | None posted |
| Feb 20, 2001 | Supplement 15Manufacturing | Approved | None posted |
| Jul 11, 2000 | Supplement 14Manufacturing | Approved | None posted |
| Jul 11, 2000 | Supplement 13Manufacturing | Approved | None posted |
| Nov 22, 1991 | Supplement 25Labeling | Approved | None posted |
| Nov 22, 1991 | Supplement 12Labeling | Approved | None posted |
| Feb 7, 1991 | Supplement 10Manufacturing | Approved | None posted |
| Sep 3, 1987 | Supplement 5Manufacturing | Approved | None posted |
| May 15, 1986 | Supplement 2Manufacturing | Approved | None posted |
| May 15, 1986 | Supplement 1Manufacturing | Approved | None posted |
| Aug 6, 1985 | 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