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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 202080


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NDA 202080 describes OXAYDO, which is a drug marketed by Zyla 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 OXAYDO profile page.

The generic ingredient in OXAYDO is oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the oxycodone hydrochloride profile page.
Summary for 202080
Tradename:OXAYDO
Applicant:Zyla
Ingredient:oxycodone hydrochloride
Patents:2
Pharmacology for NDA: 202080
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 202080
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXAYDO oxycodone hydrochloride TABLET;ORAL 202080 NDA Zyla Life Sciences US LLC 69344-113 69344-113-11 100 TABLET in 1 BOTTLE (69344-113-11)
OXAYDO oxycodone hydrochloride TABLET;ORAL 202080 NDA Zyla Life Sciences US LLC 69344-213 69344-213-11 100 TABLET in 1 BOTTLE (69344-213-11)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Jun 17, 2011TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Mar 16, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:May 26, 2024Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength7.5MG
Approval Date:Jun 17, 2011TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Mar 16, 2025Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 202080

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Zyla OXAYDO oxycodone hydrochloride TABLET;ORAL 202080-002 Jun 17, 2011 ⤷  Sign Up ⤷  Sign Up
Zyla OXAYDO oxycodone hydrochloride TABLET;ORAL 202080-002 Jun 17, 2011 ⤷  Sign Up ⤷  Sign Up
Zyla OXAYDO oxycodone hydrochloride TABLET;ORAL 202080-001 Jun 17, 2011 ⤷  Sign Up ⤷  Sign Up
Zyla OXAYDO oxycodone hydrochloride TABLET;ORAL 202080-001 Jun 17, 2011 ⤷  Sign Up ⤷  Sign Up
Zyla OXAYDO oxycodone hydrochloride TABLET;ORAL 202080-001 Jun 17, 2011 ⤷  Sign Up ⤷  Sign Up
Zyla OXAYDO oxycodone hydrochloride TABLET;ORAL 202080-002 Jun 17, 2011 ⤷  Sign Up ⤷  Sign Up
Zyla OXAYDO oxycodone hydrochloride TABLET;ORAL 202080-001 Jun 17, 2011 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.