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ADEMPAS (nda204819)- (0.5MG,1MG,1.5MG,2MG,2.5MG)

RIOCIGUAT BAYER HLTHCARE
0.5MG,1MG,1.5MG,2MG,2.5MG
Yes No
2034-Feb-18 2018-Oct-08
2020-Oct-08 None
None No
Adempas is a soluble guanylate cyclase (sGC) stimulator indicated for the treatment of adults with: • Persistent/recurrent Chronic Thromboembolic Pulmonary Hypertension (CTEPH) (WHO Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class. • Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve WHO functional class and to delay clinical worsening.
1 1 0
Total Other Developers 3
Drugs with Suitability No
0.5MG ** ** - - -
1MG ** ** - - -
1.5MG ** ** - - -
2MG ** ** - - -
2.5MG ** ** - - -
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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