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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204819

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ADEMPAS (RIOCIGUAT)
0.5MG
Marketing Status: Prescription
Active Ingredient: RIOCIGUAT
Proprietary Name: ADEMPAS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N204819
Product Number: 001
Approval Date: Oct 8, 2013
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ADEMPAS (RIOCIGUAT)
1MG
Marketing Status: Prescription
Active Ingredient: RIOCIGUAT
Proprietary Name: ADEMPAS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N204819
Product Number: 002
Approval Date: Oct 8, 2013
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ADEMPAS (RIOCIGUAT)
1.5MG
Marketing Status: Prescription
Active Ingredient: RIOCIGUAT
Proprietary Name: ADEMPAS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N204819
Product Number: 003
Approval Date: Oct 8, 2013
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ADEMPAS (RIOCIGUAT)
2MG
Marketing Status: Prescription
Active Ingredient: RIOCIGUAT
Proprietary Name: ADEMPAS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N204819
Product Number: 004
Approval Date: Oct 8, 2013
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ADEMPAS (RIOCIGUAT)
2.5MG
Marketing Status: Prescription
Active Ingredient: RIOCIGUAT
Proprietary Name: ADEMPAS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N204819
Product Number: 005
Approval Date: Oct 8, 2013
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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