Treats ocular hypertension and chronic open-angle glaucoma. NDA 19270, held by Sandoz. Betaxolol Hydrochloride.
As of Nov 13, 2026, NDA 19270 (Betoptic), held by Sandoz, was first approved by FDA on Aug 30, 1985, with 33 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Betaxolol Hydrochloride Ophthalmic Solution has been shown to be effective in lowering intraocular pressure and is indicated in the treatment of ocular hypertension and chronic open-angle glaucoma. It may be used alone or in combination with other anti-glaucoma drugs. In clinical studies, Betaxolol Hydrochloride Ophthalmic Solution was safely used to lower intraocular pressure in 47 patients with both glaucoma and reactive airway disease who were followed for a mean period of 15 months. However, caution should be used in treating patients with severe reactive airway disease or a history of asthma.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 30, 1985 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| BetopticEQ 0.5% BASE · solution/drops;ophthalmic | Betaxolol Hydrochloride | RxReference drug |
| Aug 5, 2016 | Supplement 38Manufacturing · Priority review | Approved | None posted |
| May 5, 2016 | Supplement 36Manufacturing · Priority review | Approved | None posted |
| May 5, 2016 | Supplement 37Manufacturing · Priority review | Approved | None posted |
| May 11, 2015 | Supplement 35Manufacturing · Priority review | Approved | None posted |
| Sep 25, 2014 | Supplement 34Manufacturing · Priority review | Approved | None posted |
| Feb 14, 2006 | Supplement 31Labeling · Standard review | Approved | |
| Dec 4, 2002 | Supplement 29Manufacturing · Priority review | Approved | None posted |
| Mar 13, 2002 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| Mar 16, 2001 | Supplement 27Manufacturing · Priority review | Approved | None posted |
| Feb 18, 2000 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| Aug 17, 1999 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Apr 7, 1999 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Mar 26, 1999 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| Mar 11, 1999 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Feb 5, 1999 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| Aug 4, 1998 | Supplement 20Manufacturing · Priority review | Approved | None posted |
| Jan 15, 1998 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| Nov 1, 1995 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Nov 1, 1995 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Jan 22, 1993 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Oct 28, 1991 | Supplement 11Labeling | Approved | None posted |
| Apr 10, 1991 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Feb 14, 1991 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Jul 9, 1990 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Jul 19, 1989 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Aug 31, 1988 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Jul 13, 1988 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Sep 24, 1987 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Nov 4, 1986 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Jul 7, 1986 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| May 27, 1986 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Dec 12, 1985 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Dec 12, 1985 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Aug 30, 1985 | Original applicationNew molecular entity · Priority 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
