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Last Updated: April 20, 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-two 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
Formulation / Manufacturing:see details
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:⤷  Try a TrialPatent Expiration:Mar 16, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent 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:⤷  Try a TrialPatent 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 202080-001 Jun 17, 2011 ⤷  Try a Trial ⤷  Try a Trial
Zyla OXAYDO oxycodone hydrochloride TABLET;ORAL 202080-001 Jun 17, 2011 ⤷  Try a Trial ⤷  Try a Trial
Zyla OXAYDO oxycodone hydrochloride TABLET;ORAL 202080-001 Jun 17, 2011 ⤷  Try a Trial ⤷  Try a Trial
Zyla OXAYDO oxycodone hydrochloride TABLET;ORAL 202080-002 Jun 17, 2011 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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