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Details for New Drug Application (NDA): 206316

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NDA 206316 describes SAVAYSA, which is a drug marketed by Daiichi Sankyo and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the SAVAYSA profile page.

The generic ingredient in SAVAYSA is edoxaban tosylate. One supplier is listed for this compound. Additional details are available on the edoxaban tosylate profile page.

Summary for NDA: 206316

Tradename:
SAVAYSA
Applicant:
Daiichi Sankyo
Ingredient:
edoxaban tosylate
Patents:2

Pharmacology for NDA: 206316

Mechanism of ActionFactor Xa Inhibitors

Suppliers and Packaging for NDA: 206316

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SAVAYSA
edoxaban tosylate
TABLET;ORAL 206316 NDA Daiichi Sankyo, Inc. 65597-201 65597-201-07 7 TABLET, FILM COATED in 1 BOTTLE (65597-201-07)
SAVAYSA
edoxaban tosylate
TABLET;ORAL 206316 NDA Daiichi Sankyo, Inc. 65597-201 65597-201-10 10 TABLET, FILM COATED in 1 BLISTER PACK (65597-201-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 15MG BASE
Approval Date:Jan 8, 2015TE:RLD:No
Patent:7,365,205Patent Expiration:Jun 12, 2023Product Flag?Substance Flag?YDelist Request?
Patent:9,149,532Patent Expiration:Mar 28, 2028Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Jan 8, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY


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