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Approved Drug Products containing Riociguat listed in the FDA Orange Book. Original Data : FDA Website

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01 5BAYER HLTHCARE

02 5MSN

03 4TEVA PHARMS USA INC

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PharmaCompass

01

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

RIOCIGUAT

Brand Name : ADEMPAS

Dosage Form : TABLET;ORAL

Dosage Strength : 0.5MG

Approval Date : 2013-10-08

Application Number : 204819

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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02

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

RIOCIGUAT

Brand Name : ADEMPAS

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG

Approval Date : 2013-10-08

Application Number : 204819

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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03

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

RIOCIGUAT

Brand Name : ADEMPAS

Dosage Form : TABLET;ORAL

Dosage Strength : 1.5MG

Approval Date : 2013-10-08

Application Number : 204819

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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04

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

RIOCIGUAT

Brand Name : ADEMPAS

Dosage Form : TABLET;ORAL

Dosage Strength : 2MG

Approval Date : 2013-10-08

Application Number : 204819

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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05

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

RIOCIGUAT

Brand Name : ADEMPAS

Dosage Form : TABLET;ORAL

Dosage Strength : 2.5MG

Approval Date : 2013-10-08

Application Number : 204819

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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06

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

RIOCIGUAT

Brand Name : RIOCIGUAT

Dosage Form : TABLET;ORAL

Dosage Strength : 0.5MG

Approval Date : 2022-09-01

Application Number : 211135

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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07

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

RIOCIGUAT

Brand Name : RIOCIGUAT

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG

Approval Date :

Application Number : 211044

RX/OTC/DISCN :

RLD :

TE Code :

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08

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

RIOCIGUAT

Brand Name : RIOCIGUAT

Dosage Form : TABLET;ORAL

Dosage Strength : 1.5MG

Approval Date :

Application Number : 211044

RX/OTC/DISCN :

RLD :

TE Code :

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09

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

RIOCIGUAT

Brand Name : RIOCIGUAT

Dosage Form : TABLET;ORAL

Dosage Strength : 2MG

Approval Date :

Application Number : 211044

RX/OTC/DISCN :

RLD :

TE Code :

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10

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

RIOCIGUAT

Brand Name : RIOCIGUAT

Dosage Form : TABLET;ORAL

Dosage Strength : 2.5MG

Approval Date :

Application Number : 211044

RX/OTC/DISCN :

RLD :

TE Code :

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