OCUCLEAR Ophthalmic Solution (0.025% OxyMetazoline HCl) Discontinued

OCUCLEAR is an ophthalmic solution (drops) marketed under product number 001. The product route is ophthalmic, dosage form is a solution/drops, and it is not a reference drug. Its marketing status is listed as discontinued. The active ingredient is OXYMETAZOLINE HYDROCHLORIDE at a strength of 0.025%, and no reference standard is indicated. The FDA submission history for OCUCLEAR includes an original Type 3 new dosage form application (submission 1, approved on 30 May 1986). Subsequent supplemental submissions were approved for manufacturing (CMC) on 20 Aug 1986 (submission 1), 3 Aug 1987 (submission 2), 4 Aug 1987 (submission 4), 30 Mar 1989 (submission 6), 6 Apr 1989 (submission 8), 13 Nov 1996 (submission 13), 14 Jul 1997 (submission 14), 24 Jan 2001 (submission 15), and 6 Jun 2001 (submission 16). A labeling supplement was approved on 24 Aug 1989 (submission 11). All listed submissions have a status of approved (AP).