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01 5Biogen

02 1Reata Pharmaceuticals

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PharmaCompass

01

Organic Process R&D
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Organic Process R&D
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OMAVELOXOLONE

Brand Name : SKYCLARYS

Dosage Form : CAPSULE;ORAL

Dosage Strength : 50MG

Packaging :

Approval Date : 2023-02-28

Application Number : 216718

Regulatory Info : RX

Registration Country : USA

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02

Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

Omaveloxolon

Brand Name : Skyclarys

Dosage Form : Capsule

Dosage Strength : 50mg

Packaging :

Approval Date : 09/02/2024

Application Number : 20221201000178

Regulatory Info : Approved

Registration Country : Sweden

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03

Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

Omaveloxolone

Brand Name : Skyclarys

Dosage Form : Hard Capsule

Dosage Strength : 50mg

Packaging :

Approval Date : 24/09/2024

Application Number : 69610

Regulatory Info : Allowed

Registration Country : Switzerland

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04

Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

OMAVELOXOLONE

Brand Name : SKYCLARYS

Dosage Form : CAPSULE

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number : 2556219

Regulatory Info : Prescription

Registration Country : Canada

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05

Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

Omaveloxolone

Brand Name : Skyclarys

Dosage Form : Hard Capsule

Dosage Strength : 50MG

Packaging :

Approval Date : 2024-02-29

Application Number : 1231786001

Regulatory Info : Authorized

Registration Country : Spain

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06

Organic Process R&D
Not Confirmed
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Organic Process R&D
Not Confirmed

Omaveloxolone

Brand Name : Skyclary's

Dosage Form : Kapsel, hard

Dosage Strength : 50 mg

Packaging : Boks 90item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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