FDA.reportPublic FDA data

DASABUVIR SODIUM MONOHYDRATE - Food and Drug Administration

Set ID
0b1bb9d1-e628-4e7c-aada-fd6532257932
Type
Indexing - product concept
Effective date
2015-04-16
Version
1
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
These highlights do not include all the information needed to use RITONAVIR TABLETS safely and effectively. See full prescribing information for RITONAVIR TABLETS. RITONAVIR tablets, for oral use Initial U.S. Approval: 1996Product nameAurobindo Pharma Limited2026-09-17
These highlights do not include all the information needed to use LOPINAVIR AND RITONAVIR TABLETS safely and effectively. See full prescribing information for LOPINAVIR AND RITONAVIR TABLETS. LOPINAVIR AND RITONAVIR tablets, for oral use Initial U.S. Approval: 2000Product nameMacleods Pharmaceuticals Limited2026-08-27
These highlights do not include all the information needed to use RITONAVIR TABLETS safely and effectively. See full prescribing information for RITONAVIR TABLETS. RITONAVIR tablets, for oral use Initial U.S. Approval: 1996Product nameAmneal Pharmaceuticals LLC | Amneal Pharmaceuticals, LLC2026-08-06
These highlights do not include all the information needed to use KALETRA safely and effectively. See full prescribing information for KALETRA. KALETRA ® (lopinavir and ritonavir) tablet, for oral use KALETRA ® (lopinavir and ritonavir) oral solution Initial U.S. Approval: 2000Product nameAbbVie Inc.2026-07-23
These highlights do not include all the information needed to use NORVIR safely and effectively. See full prescribing information for NORVIR. NORVIR ® (ritonavir) tablets, for oral use NORVIR ® (ritonavir) oral powder Initial U.S. Approval: 1996Product nameAbbVie Inc.2026-07-23
These highlights do not include all the information needed to use RITONAVIR TABLETS safely and effectively. See full prescribing information for RITONAVIR TABLETS. RITONAVIR tablets, for oral use Initial U.S. Approval: 1996Product nameBryant Ranch Prepack2026-03-11
These highlights do not include all the information needed to use PAXLOVID safely and effectively. See full prescribing information for PAXLOVID. PAXLOVID TM (nirmatrelvir tablets; ritonavir tablets), co-packaged for oral use Initial U.S. Approval: 2023Product namePfizer Laboratories Div Pfizer Inc | Pfizer Inc | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Deutschland GmbH | Pfizer Italia S.r.l. | Pharmacia & Upjohn Company LLC2026-02-19
These highlights do not include all the information needed to use PAXLOVID safely and effectively. See full prescribing information for PAXLOVID. PAXLOVID TM (nirmatrelvir tablets; ritonavir tablets), co-packaged for oral use Initial U.S. Approval: 2023Product namePfizer Laboratories Div Pfizer Inc | Pfizer Inc | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Deutschland GmbH | Pfizer Italia S.r.l. | Pharmacia & Upjohn Company LLC2026-01-05
These highlights do not include all the information needed to use RITONAVIR TABLETS safely and effectively. See full prescribing information for RITONAVIR TABLETS. RITONAVIR tablets, for oral use Initial U.S. Approval: 1996Product nameNuCare Pharmaceuticals, Inc.2025-09-24
These highlights do not include all the information needed to use RITONAVIR TABLETS safely and effectively. See full prescribing information for RITONAVIR TABLETS. RITONAVIR tablets, for oral use Initial U.S. Approval: 1996Product nameBryant Ranch Prepack2025-06-05
These highlights do not include all the information needed to use RITONAVIR TABLETS safely and effectively. See full prescribing information for RITONAVIR TABLETS. RITONAVIR tablets, for oral use Initial U.S. Approval: 1996Product nameCoupler LLC2024-11-11
These highlights do not include all the information needed to use NORVIR safely and effectively. See full prescribing information for NORVIR. NORVIR (ritonavir) tablets, for oral use NORVIR (ritonavir) oral powder Initial U.S. Approval: 1996Product nameAbbVie Inc.2024-07-03
These highlights do not include all the information needed to use RITONAVIR TABLETS safely and effectively. See full prescribing information for RITONAVIR TABLETS. RITONAVIR tablets, for oral use Initial U.S. Approval: 1996Product nameAmerican Health Packaging2024-04-13
These highlights do not include all the information needed to use RITONAVIR TABLETS safely and effectively. See full prescribing information for RITONAVIR TABLETS. RITONAVIR tablets, for oral use Initial U.S. Approval: 1996Product nameAurobindo Pharma Limited2023-11-13
These highlights do not include all the information needed to use LOPINAVIR AND RITONAVIR TABLETS safely and effectively. See full prescribing information for LOPINAVIR AND RITONAVIR TABLETS. LOPINAVIR AND RITONAVIR tablets, for oral use Initial U.S. Approval: 2000Product nameLaurus Labs Limited | Laurus Labs Limited (VSP2)2023-10-20
These highlights do not include all the information needed to use KALETRA safely and effectively. See full prescribing information for KALETRA. KALETRA (lopinavir and ritonavir) tablet, for oral use KALETRA (lopinavir and ritonavir) oral solution Initial U.S. Approval: 2000Product nameNuCare Pharmaceuticals,Inc.2023-07-06
These highlights do not include all the information needed to use KALETRA safely and effectively. See full prescribing information for KALETRA. KALETRA (lopinavir and ritonavir) tablet, for oral use KALETRA (lopinavir and ritonavir) oral solution Initial U.S. Approval: 2000Product nameAbbVie Inc.2023-04-01
These highlights do not include all the information needed to use LOPINAVIR AND RITONAVIR TABLETS safely and effectively. See full prescribing information for LOPINAVIR AND RITONAVIR TABLETS. LOPINAVIR AND RITONAVIR tablets, for oral use Initial U.S. Approval: 2000Product nameNuCare Pharmaceuticals,Inc.2023-03-06
These highlights do not include all the information needed to use RITONAVIR TABLETS safely and effectively. See full prescribing information for RITONAVIR TABLETS. RITONAVIR tablets, for oral use Initial U.S. Approval:1996Product nameCipla USA Inc. | Cipla Ltd. Patalganga unit II | Shanghai Desano Chemical Pharmaceutical Co., Ltd. Binhai site2023-03-01
These highlights do not include all the information needed to use RITONAVIR TABLETS safely and effectively. See full prescribing information for RITONAVIR TABLETS. RITONAVIR tablets, for oral use Initial U.S. Approval: 1996Product nameCamber Pharmaceuticals, Inc. | Hetero Labs Limited Unit III2023-02-22
These highlights do not include all the information needed to use KALETRA safely and effectively. See full prescribing information for KALETRA. KALETRA (lopinavir and ritonavir) tablet, for oral use KALETRA (lopinavir and ritonavir) oral solution Initial U.S. Approval: 2000Product nameREMEDYREPACK INC.2021-12-08
These highlights do not include all the information needed to use LOPINAVIR AND RITONAVIR TABLETS safely and effectively. See full prescribing information for LOPINAVIR AND RITONAVIR TABLETS. LOPINAVIR AND RITONAVIR tablets, for oral use Initial U.S. Approval: 2000Product nameMacleods Pharmaceuticals Limited2021-06-05
These highlights do not include all the information needed to use LOPINAVIR AND RITONAVIR TABLETS safely and effectively. See full prescribing information for LOPINAVIR AND RITONAVIR TABLETS. LOPINAVIR and RITONAVIR tablets, for oral use Initial U.S. Approval: 2000Product nameCamber Pharmaceuticals, Inc. | Hetero Labs Limited Unit III2021-06-03
These highlights do not include all the information needed to use RITONAVIR TABLETS safely and effectively. See full prescribing information for RITONAVIR TABLETS. RITONAVIR tablets, for oral use Initial U.S. Approval: 1996Product nameAmneal Pharmaceuticals LLC | Amneal Pharmaceuticals, LLC2020-11-30
RedPharm Drug, Inc. human prescription drug labelProduct nameRedPharm Drug, Inc.2020-01-20
Mylan Laboratories Limited human prescription drug labelProduct nameMylan Laboratories Limited2019-02-06
These highlights do not include all the information needed to use NORVIR safely and effectively. See full prescribing information for NORVIR. NORVIR (ritonavir) tablets, for oral use NORVIR (ritonavir) oral solution NORVIR (ritonavir) oral powder Initial U.S. Approval: 1996Product nameDOH CENTRAL PHARMACY2019-01-22
These highlights do not include all the information needed to use KALETRA safely and effectively. See full prescribing information for KALETRA. KALETRA (lopinavir/ritonavir) tablets, film coated for oral use KALETRA (lopinavir/ritonavir) solution for oral use Initial U.S. Approval: 2000Product nameDOH CENTRAL PHARMACY2017-02-03
These highlights do not include all the information needed to use KALETRA safely and effectively. See full prescribing information for KALETRA. KALETRA (lopinavir/ritonavir) Tablet, Film Coated for Oral use KALETRA (lopinavir/ritonavir) Solution for Oral use Initial U.S. Approval: 2000Product nameDispensing Solutions, Inc. | PSS World Medical, Inc.2012-10-10
These highlights do not include all the information needed to use KALETRA safely and effectively. See full prescribing information for KALETRA. KALETRA (lopinavir/ritonavir) Tablet, Film Coated for Oral use KALETRA (lopinavir/ritonavir) Solution for Oral use Initial U.S. Approval: 2000Product nameDispensing Solutions, Inc. | PSS World Medical, Inc.2012-10-10
These highlights do not include all the information needed to use KALETRA safely and effectively. See full prescribing information for KALETRA. KALETRA (lopinavir and ritonavir) Tablet, Film Coated for Oral use KALETRA (lopinavir and ritonavir) Solution for Oral use Initial U.S. Approval: 2000Product namePhysicians Total Care, Inc.2012-04-06
These highlights do not include all the information needed to use KALETRA safely and effectively. See full prescribing information for KALETRA. KALETRA (lopinavir and ritonavir) Tablet, Film Coated for Oral use KALETRA (lopinavir and ritonavir) Solution for Oral use Initial U.S. Approval: 2000Product nameHHS/Program Support Center/Supply Service Center | HHS Supply Service Center - Perry Point, MD 219022012-03-06
These highlights do not include all the information needed to use KALETRA safely and effectively. See full prescribing information for KALETRA. KALETRA (lopinavir and ritonavir) Tablet, Film Coated for Oral use KALETRA (lopinavir and ritonavir) Solution for Oral use Initial U.S. Approval: 2000Product nameRebel Distributors Corp2010-12-28