NDA 13422, held by Harrow Eye. Dexamethasone.
As of Nov 13, 2026, NDA 13422 (Maxidex), held by Harrow Eye, was first approved by FDA on Jun 20, 1962, with 32 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 20, 1962 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Maxidex0.1% · suspension/drops;ophthalmic | Dexamethasone | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 10, 2021 | Supplement 49Labeling · Standard review | Approved | |
| May 14, 2021 | Supplement 46Labeling · Standard review | Approved | |
| Nov 3, 2017 | Supplement 45Labeling · Standard review | Approved | |
| Aug 5, 2016 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Mar 10, 2016 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Apr 7, 2015 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Sep 27, 2013 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Apr 17, 2003 | Supplement 35Labeling · Standard review | Approved | |
| Dec 11, 2002 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Dec 4, 2002 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Feb 4, 2000 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Aug 17, 1999 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Apr 7, 1999 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Mar 11, 1999 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Feb 5, 1999 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Aug 4, 1998 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1996 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Sep 26, 1996 | Supplement 24Labeling · Standard review | Approved | None posted |
| Mar 18, 1996 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Nov 1, 1995 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Nov 1, 1995 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Jun 14, 1995 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| May 31, 1990 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Dec 6, 1989 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Nov 28, 1989 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1988 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1984 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Mar 21, 1984 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Aug 5, 1983 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Aug 5, 1981 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jul 6, 1979 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jul 6, 1979 | Supplement 10Labeling | Approved | None posted |
| Jun 20, 1962 | 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
