Details for New Drug Application (NDA): 007337

NDA 007337 describes PERCODAN-DEMI, which is a drug marketed by Endo Operations and is included in one NDA. Additional details are available on the PERCODAN-DEMI profile page.

The generic ingredient in PERCODAN-DEMI is aspirin; oxycodone hydrochloride; oxycodone terephthalate. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; oxycodone hydrochloride; oxycodone terephthalate profile page.

Summary for 007337

Tradename:	PERCODAN-DEMI
Applicant:	Endo Operations
Ingredient:	aspirin; oxycodone hydrochloride
Patents:	0

Profile for product number 005

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 006

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 007

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	325MG;4.8355MG
Approval Date:	Aug 5, 2005	TE:	AA	RLD:	Yes

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