NDA 50065, held by Sandoz. Dexamethasone; Neomycin Sulfate; Polymyxin B Sulfate.
As of Nov 13, 2026, NDA 50065 (Maxitrol), held by Sandoz, was first approved by FDA on Jul 19, 1963, with 46 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 19, 1963 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Maxitrol0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM · ointment;ophthalmic | Dexamethasone; Neomycin Sulfate; Polymyxin B Sulfate | RxReference drug |
| May 14, 2021 | Supplement 65Labeling · Standard review | Approved | |
| Dec 18, 2017 | Supplement 64Labeling · Standard review | Approved | |
| Apr 12, 2017 | Supplement 61Labeling · Standard review | Approved | |
| Oct 6, 2015 | Supplement 60Manufacturing | Approved | None posted |
| Dec 18, 2012 | Supplement 57Manufacturing | Approved | None posted |
| Dec 10, 2012 | Supplement 58Manufacturing | Approved | None posted |
| Jul 15, 2004 | Supplement 44Manufacturing | Approved | |
| Jul 15, 2004 | Supplement 43Labeling · Standard review | Approved | |
| Jul 23, 2003 | Supplement 40Labeling · Standard review | Approved | |
| Jul 23, 2003 | Supplement 39Manufacturing | Approved | |
| Dec 11, 2002 | Supplement 41Manufacturing | Approved | None posted |
| Feb 9, 2001 | Supplement 38Manufacturing | Approved | None posted |
| Sep 28, 1999 | Supplement 37Manufacturing | Approved | None posted |
| Apr 7, 1999 | Supplement 36Manufacturing | Approved | None posted |
| Feb 5, 1999 | Supplement 35Manufacturing | Approved | None posted |
| May 29, 1998 | Supplement 34Manufacturing | Approved | None posted |
| Nov 29, 1996 | Supplement 32Manufacturing | Approved | None posted |
| Mar 18, 1996 | Supplement 31Manufacturing | Approved | None posted |
| Aug 30, 1995 | Supplement 29Labeling · Standard review | Approved | None posted |
| May 18, 1995 | Supplement 30Manufacturing | Approved | None posted |
| Sep 17, 1992 | Supplement 10Manufacturing | Approved | None posted |
| Feb 3, 1992 | Supplement 13Manufacturing | Approved | None posted |
| Mar 22, 1988 | Supplement 9Manufacturing | Approved | None posted |
| Jun 30, 1987 | Supplement 7Labeling | Approved | None posted |
| Jun 30, 1987 | Supplement 6Manufacturing | Approved | None posted |
| May 15, 1987 | Supplement 8Labeling | Approved | None posted |
| Jul 25, 1984 | Supplement 5Manufacturing | Approved | None posted |
| Apr 23, 1984 | Supplement 4Manufacturing | Approved | None posted |
| Dec 30, 1983 | Supplement 3Labeling | Approved | None posted |
| Nov 23, 1983 | Supplement 2Manufacturing | Approved | None posted |
| Jul 11, 1983 | Supplement 28Manufacturing | Approved | None posted |
| Jul 11, 1983 | Supplement 1Manufacturing | Approved | None posted |
| Jul 29, 1982 | Supplement 27Labeling | Approved | None posted |
| Jun 17, 1981 | Supplement 26Manufacturing | Approved | None posted |
| Apr 13, 1981 | Supplement 25Manufacturing | Approved | None posted |
| May 10, 1978 | Supplement 24Labeling | Approved | None posted |
| Feb 20, 1973 | Supplement 23Manufacturing | Approved | None posted |
| Feb 8, 1973 | Supplement 22Manufacturing | Approved | None posted |
| Feb 8, 1973 | Supplement 21Manufacturing | Approved | None posted |
| Sep 19, 1972 | Supplement 20Labeling | Approved | None posted |
| Jul 12, 1972 | Supplement 19Manufacturing | Approved | None posted |
| Apr 17, 1972 | Supplement 18Manufacturing | Approved | None posted |
| Apr 10, 1972 | Supplement 17Manufacturing | Approved | None posted |
| Aug 9, 1971 | Supplement 16Labeling | Approved | None posted |
| Jul 22, 1971 | Supplement 15Labeling | Approved | None posted |
| Jun 4, 1970 | Supplement 14Manufacturing | Approved | None posted |
| Jul 19, 1963 | 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
