FDA.reportPublic FDA data

MACITENTAN Pharmacologic Class Indexing

Class set ID
02817bcf-ec22-409b-bc55-4d200ab4a2dd
Version
2
Effective date
20180813
Type
Indexing - Pharmacologic Class

Mapped DailyMed Labels#

Label, Manufacturer, Effective table
LabelManufacturerEffectiveSPL version
These highlights do not include all the information needed to use MACITENTAN TABLETS safely and effectively. See full prescribing information for MACITENTAN TABLETS. MACITENTAN tablets, for oral use Initial U.S. Approval: 2013Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Global FZE | Umedica Laboratories Pvt Ltd202605206
These highlights do not include all the information needed to use MACITENTAN TABLETS safely and effectively. See full prescribing information for MACITENTAN TABLETS. MACITENTAN tablets, for oral use Initial U.S. Approval: 2013Novugen Pharma (USA) LLC | Seasons Biotechnology (Taizhou) Co., Ltd.202605051
These highlights do not include all the information needed to use MACITENTAN TABLETS safely and effectively. See full prescribing information for MACITENTAN TABLETS. MACITENTAN tablets, for oral use Initial U.S. Approval: 2013Aurobindo Pharma Limited | APL HEALTHCARE LIMITED202604296
These highlights do not include all the information needed to use MACITENTAN TABLETS safely and effectively. See full prescribing information for MACITENTAN TABLETS. MACITENTAN tablets, for oral use Initial U.S. Approval: 2013Sandoz Inc | MSN LABORATORIES PRIVATE LIMITED202604061
These highlights do not include all the information needed to use MACITENTAN TABLETS safely and effectively. See full prescribing information for MACITENTAN TABLETS. MACITENTAN tablets, for oral use Initial U.S. Approval: 2013Torrent Pharmaceuticals Limited | Torrent Pharma, Inc.202603107
These highlights do not include all the information needed to use MACITENTAN TABLETS safely and effectively. See full prescribing information for MACITENTAN TABLETS. MACITENTAN tablets, for oral use Initial U.S. Approval: 2013Laurus Labs Limited | Laurus Labs Limited (VSP2)202511101
These highlights do not include all the information needed to use OPSUMIT safely and effectively. See full prescribing information for OPSUMIT. OPSUMIT ® (macitentan) tablets, for oral use Initial U.S. Approval: 2013Actelion Pharmaceuticals US, Inc. | Allpack Group AG | Lonza AG | JETPHARMA SA | Patheon France S.A.S. | Excella GmbH & Co. KG | MICRO-MACINAZIONE SA | Johnson & Johnson Private Ltd. | SGS Institut Fresenius GmbH2025041135
These highlights do not include all the information needed to use OPSYNVI safely and effectively. See full prescribing information for OPSYNVI. OPSYNVI ® (macitentan and tadalafil) tablets, for oral use Initial U.S. Approval: 2024Actelion Pharmaceuticals US, Inc. | SMS Pharmaceuticals Limited | Vimta Labs Limited | Lonza AG | Jetpharma SA | PENN PHARMACEUTICAL SERVICES LIMITED | Janssen Cilag SpA | Almac Pharma Services Limited | Johnson & Johnson Private Limited202504113