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OPSYNVI (NDA218490)- (10MG;20MG,10MG;40MG)

MACITENTAN; TADALAFIL ACTELION
10MG;20MG,10MG;40MG
No Yes
2029-Apr-18 Expired
None 2027-Mar-22
None No
OPSYNVI is a combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor, indicated for chronic treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adult patients of WHO functional class (FC) II-III. Individually, macitentan reduces the risk of clinical worsening events and hospitalization, and tadalafil improves exercise ability.
0 0 0
Total Other Developers None
Drugs with Suitability No
10MG;20MG ** ** - - -
10MG;40MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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