NDA 20706, held by Novartis. Emedastine Difumarate.
As of Nov 14, 2026, NDA 20706 (Emadine), held by Novartis, was first approved by FDA on Dec 29, 1997, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 29, 1997 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Emadine0.05% · solution/drops;ophthalmic | Emedastine Difumarate | DiscontinuedReference drug |
| May 12, 2003 | Supplement 11Labeling · Standard review | Approved | |
| Dec 4, 2002 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Mar 13, 2002 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Mar 16, 2001 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Feb 18, 2000 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Dec 20, 1999 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Sep 28, 1999 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Aug 17, 1999 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Feb 5, 1999 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jan 4, 1999 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Aug 4, 1998 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Dec 29, 1997 | Original applicationNew molecular entity · Standard review | 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
