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

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01 3DAIICHI SANKYO INC

02 3ZYDUS PHARMS USA INC

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EDOXABAN TOSYLATE

Brand Name : SAVAYSA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 15MG BASE

Approval Date : 2015-01-08

Application Number : 206316

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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02

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EDOXABAN TOSYLATE

Brand Name : SAVAYSA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 30MG BASE

Approval Date : 2015-01-08

Application Number : 206316

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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03

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EDOXABAN TOSYLATE

Brand Name : SAVAYSA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 60MG BASE

Approval Date : 2015-01-08

Application Number : 206316

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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04

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EDOXABAN

Brand Name : EDOXABAN

Dosage Form : TABLET;ORAL

Dosage Strength : 15MG

Approval Date :

Application Number : 213064

RX/OTC/DISCN :

RLD :

TE Code :

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05

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EDOXABAN

Brand Name : EDOXABAN

Dosage Form : TABLET;ORAL

Dosage Strength : 30MG

Approval Date :

Application Number : 213064

RX/OTC/DISCN :

RLD :

TE Code :

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06

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EDOXABAN

Brand Name : EDOXABAN

Dosage Form : TABLET;ORAL

Dosage Strength : 60MG

Approval Date :

Application Number : 213064

RX/OTC/DISCN :

RLD :

TE Code :

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