Skip to main content
Search results
https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/index-drug-specific-information
11 months ago -
Dalfampridine Dalmane (flurazepam) Darunavir Daytrana (methylphenidate) Deferasirox...(ezogabine) Pramipexole Prasugrel Prezista (darunavir) Prinivil ...
https://www.fda.gov/media/71502/download
5 months ago -
CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE DARUNAVIR, DARUNAVIR DEXAMETHASONE SODIUM PHOSPHATE...BISULFATE COLCHICINE, COLCHICINE DARUNAVIR, DARUNAVIR ...
https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/darunavir-ethalolate-marketed-prezista-information
11 months ago -
Darunavir Ethalolate (marketed as Prezista) Information...Darunavir Ethalolate (marketed as Prezista) Information Share Post Linkedin...Labeling from ...
https://www.fda.gov/media/175015/download
about 1 year ago -
Prezcobix (cobicistat;darunavir) -PediatricReview - Nov2023 - final Department...Product Name: Prezcobix (cobicistat; darunavir) Pediatric Labeling ...
https://www.fda.gov/media/175019/download
about 1 year ago -
Symtuza (cobicistat;darunavir;FTC;TAF) - Nov2023 Department of Health and Human...Product Name: Symtuza (cobicistat; darunavir; emtricitabine ...
https://www.fda.gov/media/177082/download
9 months ago -
LTD S 12/22/2023 Y NDA 209847 (2) DARUNAVIR AND RITONAVIR MYLAN LABORATORIES
https://www.fda.gov/media/71494/download
5 months ago -
HYDROBROMIDE, DARIFENACIN HYDROBROMIDE DARUNAVIR, DARUNAVIR DASETTA 1/35, ETHINYL ESTRADIOL...LETERMOVIR PREZCOBIX, COBICISTAT PREZISTA, DARUNAVIR ...
https://www.fda.gov/drugs/development-resources/reviews-pediatric-studies-conducted-under-bpca-and-prea-2012-present
4 months ago -
Medical (PDF - 3.5 MB) None None PREA Darunavir, cobicistat, emtricitabine, and tenofovir...None Statistical (PDF -280KB) BPCA Darunavir and ...
https://www.fda.gov/media/160597/download
over 5 years ago -
...1 Oral 591 varenicline 1 Oral 592 darunavir 1 Oral 593 aliskiren 1 Oral 594 dasatinib
https://www.fda.gov/drugs/accelerated-approval-program/verified-clinical-benefit-infectious-disease-accelerated-approvals-excluding-vaccines
4 months ago -
HIV-1 8/6/2007 11/25/2008 Prezista (darunavir) For the treatment of human immunodeficiency
https://www.fda.gov/media/159989/download
over 2 years ago -
...and is supported by data from the darunavir/ritonavir package insert3 and a study...exposure when coadministered with darunavir/ritonavir (600 mg/100 ...
https://www.fda.gov/media/145453/download
about 6 years ago -
...202073 LUPIN LIMITED DARUNAVIR AMORPHOUS 202073 - DARUNAVIR AMORPHOUS LUPIN LIMITED...LABS LTD UNIT III DARUNAVIR ETHANOLATE 202083 - DARUNAVIR ...
https://www.fda.gov/media/158928/download
over 2 years ago -
...lower-or-higher-medication-doses Darunavir/cobicistat drug combination in pregnancy...Zorrilla C et al. Reduced exposure to darunavir and cobicistat ...
https://www.fda.gov/drugs/drug-safety-and-availability/comunicado-de-la-fda-sobre-la-seguridad-de-los-medicamentos-importantes-interacciones-entre-el
over 3 years ago -
...ritonavir (atazanavir, lopinavir, darunavir) tiene el potencial de reducir la...ritonavir (atazanavir, lopinavir, darunavir) tiene el potencial de ...
https://www.fda.gov/media/104540/download
over 8 years ago -
...210455 Janssen Products, LP Symtuza (darunavir, cobicistat, emtricitabine, and tenofovir...205395 Janssen Products, LP Prezcobix (darunavir and ...
https://www.fda.gov/advisory-committees/pediatric-advisory-committee/pediatric-advisory-recommendations-and-updates
4 months ago -
Prezcobix tablets (darunavir/cobicistat) Prezcobix tablets (darunavir/cobicistat)Pediatric...Review 12/21/2023 Symtuza tablets (darunavir, cobicistat ...
https://www.fda.gov/media/177084/download
9 months ago -
SPA P,O 12/18/2023 NDA 209847 (2) DARUNAVIR AND RITONAVIR MYLAN LABORATORIES
https://www.fda.gov/drugs/human-immunodeficiency-virus-hiv/fda-approved-product-labeling-prezcobix-and-evotaz-use-pediatric-patients
over 4 years ago -
...the product labeling for PREZCOBIX (darunavir/cobicistat) for use in pediatric...the product labeling for PREZCOBIX (darunavir/cobicistat) for use in ...
https://www.fda.gov/drugs/development-resources/reviews-pediatric-studies-conducted-under-bpca-and-prea-2007-2012
5 months ago -
None Statistical (PDF -4MB) Both Darunavir - Prezista Tibotec Medical (PDF -2MB)...pharmacology (PDF - 949KB) None Both Darunavir - Prezista Tibotec ...
https://www.fda.gov/media/142206/download
about 4 years ago -
NDA 206353: 12/6/2019 NDA 205395: Darunavir and cobicistat Generic Name NDA 206353:...10/3/2019 to include approval of darunavir and cobicistat ...