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-three 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 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
Patent:	7,201,920	Patent Expiration:	Mar 16, 2025	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	9,492,443	Patent Expiration:	May 26, 2024	Product Flag?	Y	Substance Flag?		Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	7.5MG
Approval Date:	Jun 17, 2011	TE:		RLD:	Yes
Patent:	7,201,920	Patent Expiration:	Mar 16, 2025	Product Flag?	Y	Substance Flag?		Delist Request?

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	8,637,540	⤷ Subscribe
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-001	Jun 17, 2011	9,492,443	⤷ Subscribe
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-001	Jun 17, 2011	7,510,726	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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