NDA 20213, held by Bausch And Lomb. Acetylcholine Chloride.
As of Nov 13, 2026, NDA 20213 (Miochol-E), held by Bausch And Lomb, was first approved by FDA on Sep 22, 1993, with 7 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE To obtain miosis of the iris in seconds after delivery of the lens in cataract surgery, in penetrating keratoplasty, iridectomy, and other anterior segment surgery where rapid miosis may be required.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 22, 1993 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Miochol-E20MG/VIAL · for solution;ophthalmic | Acetylcholine Chloride | RxReference drug |
| Jun 17, 2016 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| May 30, 2006 | Supplement 10Manufacturing · Standard review | Approved | |
| Jan 24, 2000 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1998 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Oct 16, 1996 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Feb 29, 1996 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Aug 18, 1995 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 22, 1993 | Original applicationNew dosage form · Standard review | 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
