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Generated: November 16, 2018

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Details for New Drug Application (NDA): 210607

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NDA 210607 describes ARAKODA, which is a drug marketed by 60 Degrees Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the ARAKODA profile page.

The generic ingredient in ARAKODA is tafenoquine succinate. One supplier is listed for this compound. Additional details are available on the tafenoquine succinate profile page.
Summary for 210607
Tradename:ARAKODA
Applicant:60 Degrees Pharms
Ingredient:tafenoquine succinate
Patents:0
Suppliers and Packaging for NDA: 210607
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARAKODA tafenoquine succinate TABLET;ORAL 210607 NDA 60 Degrees Pharmaceuticals, LLC 71475-257 71475-257-01 2 BLISTER PACK in 1 CARTON (71475-257-01) > 8 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Aug 8, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 20, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Aug 8, 2021
Regulatory Exclusivity Use:NEW PRODUCT

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Healthtrust
Johnson and Johnson
Julphar
Cantor Fitzgerald
Harvard Business School
Covington
Cerilliant
Daiichi Sankyo

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