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Details for New Drug Application (NDA): 007337

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NDA 007337 describes PERCODAN-DEMI, which is a drug marketed by Endo Pharms and is included in one NDA. It is available from one supplier. 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-one drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the aspirin; oxycodone hydrochloride; oxycodone terephthalate profile page.

Summary for NDA: 007337

Tradename:
PERCODAN
Applicant:
Endo Pharms
Ingredient:
aspirin; oxycodone hydrochloride; oxycodone terephthalate
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 007337

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PERCODAN
aspirin; oxycodone hydrochloride; oxycodone terephthalate
TABLET;ORAL 007337 NDA AUTHORIZED GENERIC STAT RX USA LLC 16590-947 16590-947-30 30 TABLET in 1 BOTTLE (16590-947-30)
PERCODAN
aspirin; oxycodone hydrochloride; oxycodone terephthalate
TABLET;ORAL 007337 NDA AUTHORIZED GENERIC STAT RX USA LLC 16590-947 16590-947-60 60 TABLET in 1 BOTTLE (16590-947-60)

Summary for product number 005

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength325MG;2.25MG;0.19MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 006

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength325MG;4.5MG;0.38MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 007

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;4.8355MG
Approval Date:Aug 5, 2005TE:AARLD:Yes


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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 verifification 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.

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