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OPSUMIT (nda204410)- (10MG)

MACITENTAN ACTELION
10MG
Yes No
2029-Apr-18 2018-Oct-18
2020-Oct-18 None
None No
OPSUMIT is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to reduce the risks of disease progression and hospitalization for PAH.
3 8 0
Total Other Developers 4
Drugs with Suitability No
10MG ** ** - - -
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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