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Last Updated: March 18, 2026

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. 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. Thirty-seven 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:	0

Pharmacology for NDA: 202080

Mechanism of Action	Full 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:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Jun 17, 2011	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	7.5MG
Approval Date:	Jun 17, 2011	TE:		RLD:	Yes

Expired US Patents for NDA 202080

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

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