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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 209777


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NDA 209777 describes ROXYBOND, which is a drug marketed by Protega Pharms 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 ROXYBOND profile page.

The generic ingredient in ROXYBOND is oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the oxycodone hydrochloride profile page.
Summary for 209777
Tradename:ROXYBOND
Applicant:Protega Pharms
Ingredient:oxycodone hydrochloride
Patents:2
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 Protega Pharmaceuticals Inc 81140-101 81140-101-10 100 TABLET, COATED in 1 BOTTLE (81140-101-10)
ROXYBOND oxycodone hydrochloride TABLET;ORAL 209777 NDA Protega Pharmaceuticals Inc 81140-102 81140-102-10 100 TABLET, COATED in 1 BOTTLE (81140-102-10)

Profile for product number 001

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

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