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Last Updated: December 22, 2024

Suppliers and packages for generic ingredient: MACITENTAN; TADALAFIL


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MACITENTAN; TADALAFIL

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Actelion OPSYNVI macitentan; tadalafil TABLET;ORAL 218490 NDA Actelion Pharmaceuticals US, Inc. 66215-812-07 1 BOTTLE in 1 CARTON (66215-812-07) / 7 TABLET, FILM COATED in 1 BOTTLE 2024-03-22
Actelion OPSYNVI macitentan; tadalafil TABLET;ORAL 218490 NDA Actelion Pharmaceuticals US, Inc. 66215-812-08 1 BLISTER PACK in 1 CARTON (66215-812-08) / 7 TABLET, FILM COATED in 1 BLISTER PACK (66215-812-01) 2024-03-22
Actelion OPSYNVI macitentan; tadalafil TABLET;ORAL 218490 NDA Actelion Pharmaceuticals US, Inc. 66215-812-30 1 BOTTLE in 1 CARTON (66215-812-30) / 30 TABLET, FILM COATED in 1 BOTTLE 2024-03-22
Actelion OPSYNVI macitentan; tadalafil TABLET;ORAL 218490 NDA Actelion Pharmaceuticals US, Inc. 66215-814-10 1 BLISTER PACK in 1 CARTON (66215-814-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (66215-814-01) 2024-03-22
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

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