NDA 50592, held by Sandoz. Dexamethasone; Tobramycin.
As of Nov 13, 2026, NDA 50592 (Tobradex), held by Sandoz, was first approved by FDA on Aug 18, 1988, with 33 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE: Tobramycin and dexamethasone ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 18, 1988 | Original applicationNew combination · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tobradex0.1%;0.3% · suspension/drops;ophthalmic | Dexamethasone; Tobramycin | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 7, 2025 | Supplement 51Manufacturing | Approved | |
| May 14, 2021 | Supplement 46Labeling · Standard review | Approved | |
| May 14, 2021 | Supplement 44Labeling · Standard review | Approved | |
| Apr 24, 2020 | Supplement 43Labeling · Standard review | Approved | |
| Jun 23, 2003 | Supplement 32Labeling · Standard review | Approved | |
| Dec 11, 2002 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Dec 4, 2002 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Aug 16, 2002 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Apr 2, 2001 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Mar 16, 2001 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Jun 20, 2000 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Feb 18, 2000 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Feb 4, 2000 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Aug 17, 1999 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Apr 28, 1999 | Supplement 17Labeling · Standard review | Approved | None posted |
| Apr 7, 1999 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Mar 11, 1999 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Feb 5, 1999 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Aug 4, 1998 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Feb 11, 1998 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Sep 9, 1997 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Jul 31, 1997 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Sep 27, 1996 | Supplement 14Labeling · Standard review | Approved | None posted |
| Sep 27, 1996 | Supplement 13Labeling · Standard review | Approved | None posted |
| Sep 27, 1996 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Mar 18, 1996 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Nov 1, 1995 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Nov 1, 1995 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Aug 3, 1995 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Oct 27, 1994 | Supplement 7Labeling · Standard review | Approved | None posted |
| Aug 31, 1993 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Dec 31, 1991 | Supplement 6Labeling | Approved | None posted |
| Dec 31, 1991 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Aug 18, 1988 | Original applicationNew combination · 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
