Details for New Drug Application (NDA): 218490
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The generic ingredient in OPSYNVI is macitentan; tadalafil. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the macitentan; tadalafil profile page.
Summary for 218490
Tradename: | OPSYNVI |
Applicant: | Actelion |
Ingredient: | macitentan; tadalafil |
Patents: | 0 |
Pharmacology for NDA: 218490
Mechanism of Action | Endothelin Receptor Antagonists Phosphodiesterase 5 Inhibitors |
Suppliers and Packaging for NDA: 218490
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OPSYNVI | macitentan; tadalafil | TABLET;ORAL | 218490 | NDA | Actelion Pharmaceuticals US, Inc. | 66215-812 | 66215-812-07 | 1 BOTTLE in 1 CARTON (66215-812-07) / 7 TABLET, FILM COATED in 1 BOTTLE |
OPSYNVI | macitentan; tadalafil | TABLET;ORAL | 218490 | NDA | Actelion Pharmaceuticals US, Inc. | 66215-812 | 66215-812-08 | 1 BLISTER PACK in 1 CARTON (66215-812-08) / 7 TABLET, FILM COATED in 1 BLISTER PACK (66215-812-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;20MG | ||||
Approval Date: | Mar 22, 2024 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;40MG | ||||
Approval Date: | Mar 22, 2024 | TE: | RLD: | Yes |
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