United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2013_register executive 2013-05-11 article Notices D09002ee1c7fb8247 D09002ee1c7fb82b9 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) has determined that REV-EYES (dapiprazole hydrochloride ophthalmic solution), 0.5%, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for dapiprazole hydrochloride ophthalmic solution, 0.5%, if all other legal and regulatory requirements are met. 78 FR 27971 https://www.govinfo.gov/app/details/FR-2013-05-13/2013-11285 2013-11285 fr13my13-63 4160-01-P Docket No. FDA-2012-P-1000 https://www.govinfo.gov/app/details/FR-2013-05-13/2013-11285 https://www.govinfo.gov/content/pkg/FR-2013-05-13/html/2013-11285.htm https://www.govinfo.gov/content/pkg/FR-2013-05-13/pdf/2013-11285.pdf 1 p. 27971 27971 78 FR 27971 Determination That REV-EYES (Dapiprazole Hydrochloride Ophthalmic Solution), 0.5%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness; Federal Register Vol. 78, Issue NOTICE 2013-11285 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2012-P-1000 4160-01-P 2013-11285 Notice.

The Food and Drug Administration (FDA) has determined that REV-EYES (dapiprazole hydrochloride ophthalmic solution), 0.5%, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for dapiprazole hydrochloride ophthalmic solution, 0.5%, if all other legal and regulatory requirements are met.

David E. Markert, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301- 796-3602. Determinations that Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness: REVEYES (Dapiprazole Hydrochloride Ophthalmic Solution), 0.5 Percent , Vol. 78, no. 92 Office of the Federal Register, National Archives and Records Administration 2013-05-13 continuing daily deposited born digital 266 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2013-05-13 P0b002ee184a9620c 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr13my13 https://www.govinfo.gov/app/details/FR-2013-05-13 https://www.govinfo.gov/content/pkg/FR-2013-05-13/pdf/FR-2013-05-13.pdf https://www.govinfo.gov/content/pkg/FR-2013-05-13/xml/FR-2013-05-13.xml fdlp 27853 28109 DGPO 2013-05-11 2024-06-03 FR-2013-05-13 machine generated eng FR FR-2013-05-13 78 92