FDA.reportPublic FDA data

Application 214112

Type
ANDA
Sponsor
RHODES PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MACITENTANMACITENTANTABLET;ORAL10MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
macitentanMACITENTANApotex Corp.226049ba-9c76-0798-6725-ee027a0418202026-06-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: macitentan
generic name: MACITENTAN
MacitentanMACITENTANAurobindo Pharma Limited88b9f3b0-3f8f-47e4-bbd7-a2a785ed4ac02026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Macitentan
generic name: MACITENTAN
MacitentanMACITENTANAlembic Pharmaceuticals Limited4d9d9a84-6853-4004-b20a-8849b34453a42026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Macitentan
generic name: MACITENTAN
MacitentanMACITENTANAlembic Pharmaceuticals Inc.98b3309a-5012-42b5-b773-a38c2f52296c2026-05-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Macitentan
generic name: MACITENTAN
MACITENTANMACITENTANZydus Pharmaceuticals USA Inc.39ed1c20-99ae-4780-b040-dbebfc90018f2026-05-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: MACITENTAN
generic name: MACITENTAN
MacitentanMACITENTANTorrent Pharmaceuticals Limitedfbfae088-44e6-4296-81d1-c2b6eecacc812026-05-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Macitentan
generic name: MACITENTAN
MacitentanMACITENTANNovugen Pharma (USA) LLC8cabe7dd-1592-4764-a48a-f086288cae612026-05-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Macitentan
generic name: MACITENTAN
macitentanMACITENTANSandoz Inc91232484-55b7-47dc-bc30-e63a6b469df62026-04-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: macitentan
generic name: MACITENTAN
MacitentanMACITENTANLaurus Labs Limited93f0ab4a-4756-4915-a000-ed65b26cd61c2025-11-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Macitentan
generic name: MACITENTAN
MacitentanMACITENTANMylan Pharmaceuticals Inc.d88a13e7-cf08-4632-86be-dcd9795162962025-08-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Macitentan
generic name: MACITENTAN
MacitentanMACITENTANSun Pharmaceutical Industries, Inc.8de5c74f-b172-4485-a3f0-95e0172299d82025-06-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Macitentan
generic name: MACITENTAN
macitentanMACITENTANTeva Pharmaceuticals, Inc.b196010f-2ba2-4fa7-8e19-a58000a9563d2025-06-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: macitentan
generic name: MACITENTAN
MacitentanMACITENTANAmneal Pharmaceuticals NY LLCe153997b-7b61-4737-97bd-ff8be3c097952025-05-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Macitentan
generic name: MACITENTAN
OPSUMITMACITENTANActelion Pharmaceuticals US, Inc.1e484a50-55db-4b85-8c57-6cd1b0353abd2025-04-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MACITENTAN