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