PREZISTA · ReferencePrescription
DARUNAVIR 150MG · TABLET · ORAL
PREZISTA · ReferenceDiscontinued
DARUNAVIR 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
PREZISTA · ReferenceDiscontinued
DARUNAVIR 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
PREZISTA · ReferencePrescription
DARUNAVIR 800MG · TABLET · ORAL
PREZISTA · ReferencePrescription
DARUNAVIR 75MG · TABLET · ORAL
PREZISTA · ReferencePrescription
DARUNAVIR 600MG · TABLET · ORAL
2023-03-31Labeling · Supplement 68 · standard — Label ↗AP 2022-10-20Labeling · Supplement 67 · standard — Letter ↗AP 2022-04-14Labeling · Supplement 65 · standard — Letter ↗AP 2021-08-17Labeling · Supplement 63 · standard — Letter ↗AP 2021-07-23Labeling · Supplement 62 · standard — Label ↗AP 2020-12-22Labeling · Supplement 59 · standard — Letter ↗AP 2019-05-28Labeling · Supplement 56 · standard — Label ↗AP 2019-03-21Efficacy · Supplement 53 · standard — Label ↗AP 2019-01-31Labeling · Supplement 54 · standard — Label ↗AP 2018-09-07Labeling · Supplement 51 · standard — Label ↗AP 2018-01-25Labeling · Supplement 47 · standard — Letter ↗AP 2017-06-19Labeling · Supplement 45 · standard — Letter ↗AP 2016-09-15Labeling · Supplement 44 · 901 required — Label ↗AP 2016-06-17Efficacy · Supplement 43 · priority — Label ↗AP 2016-04-11Manufacturing (CMC) · Supplement 42 · priorityAP
2016-02-19Manufacturing (CMC) · Supplement 38 · priorityAP
2015-05-27Labeling · Supplement 36 · standard — Letter ↗AP 2015-03-27Labeling · Supplement 39 · 901 required — Label ↗AP 2015-02-03Manufacturing (CMC) · Supplement 37 · priorityAP
2014-05-08Manufacturing (CMC) · Supplement 35 · priorityAP
2014-04-07Labeling · Supplement 34 · standard — Label ↗AP 2013-11-07Labeling · Supplement 33 · standard — Letter ↗AP 2013-10-31Manufacturing (CMC) · Supplement 32 · priorityAP
2013-06-14Manufacturing (CMC) · Supplement 31 · priorityAP
2013-04-24Efficacy · Supplement 27 · standard — Letter ↗AP 2013-02-22Labeling · Supplement 30 · standard — Label ↗AP 2013-02-01Efficacy · Supplement 28 · priority — Letter ↗AP 2013-02-01Efficacy · Supplement 29 · priority — Letter ↗AP 2012-11-09Manufacturing (CMC) · Supplement 25 · priority — Label ↗AP 2012-06-01Labeling · Supplement 26 · standard — Label ↗AP 2012-02-17Labeling · Supplement 22 · 901 required — Letter ↗AP 2012-02-13Labeling · Supplement 21 · standard — Label ↗AP 2011-10-19Efficacy · Supplement 18 · standard — Label ↗AP 2010-12-13Efficacy · Supplement 17 · standard — Letter ↗AP 2010-04-26Labeling · Supplement 16 · 901 required — Label ↗AP 2010-01-27Efficacy · Supplement 13 · standard — Label ↗AP 2010-01-27Efficacy · Supplement 12 · standard — Letter ↗AP 2009-06-15Labeling · Supplement 11 · standard — Letter ↗AP 2009-06-15Labeling · Supplement 10 · standard — Label ↗AP Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.