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Generated: November 17, 2018

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Details for New Drug Application (NDA): 209777

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NDA 209777 describes ROXYBOND, which is a drug marketed by Daiichi Sankyo Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the ROXYBOND profile page.

The generic ingredient in ROXYBOND is oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the oxycodone hydrochloride profile page.
Summary for 209777
Tradename:ROXYBOND
Applicant:Daiichi Sankyo Inc
Ingredient:oxycodone hydrochloride
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 209777
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 209777
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROXYBOND oxycodone hydrochloride TABLET;ORAL 209777 NDA Daiichi Sankyo Inc. 65597-501 65597-501-10 100 TABLET, COATED in 1 BOTTLE, PLASTIC (65597-501-10)
ROXYBOND oxycodone hydrochloride TABLET;ORAL 209777 NDA Daiichi Sankyo Inc. 65597-502 65597-502-10 100 TABLET, COATED in 1 BOTTLE, PLASTIC (65597-502-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 20, 2017TE:RLD:No
Patent:➤ Try a Free TrialPatent Expiration:Aug 12, 2028Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Apr 20, 2017TE:RLD:No
Patent:➤ Try a Free TrialPatent Expiration:Aug 12, 2028Product Flag?YSubstance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Apr 20, 2017TE:RLD:No
Patent:➤ Try a Free TrialPatent Expiration:Aug 12, 2028Product Flag?YSubstance Flag?Delist Request?

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