BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

US Army
Boehringer Ingelheim
Argus Health

Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 087463

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NDA 087463 describes OXYCET, which is a drug marketed by Mallinckrodt and is included in one NDA. It is available from five suppliers. Additional details are available on the OXYCET profile page.

The generic ingredient in OXYCET is acetaminophen; oxycodone hydrochloride. There are sixty-six drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.

Summary for 087463

Formulation / Manufacturing:see details

Pharmacology for NDA: 087463

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 087463

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCET acetaminophen; oxycodone hydrochloride TABLET;ORAL 087463 ANDA Mallinckrodt, Inc. 0406-0512 0406-0512-01 100 TABLET in 1 BOTTLE (0406-0512-01)
OXYCET acetaminophen; oxycodone hydrochloride TABLET;ORAL 087463 ANDA Mallinckrodt, Inc. 0406-0512 0406-0512-62 100 TABLET in 1 BLISTER PACK (0406-0512-62)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;5MG
Approval Date:Dec 7, 1983TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Boehringer Ingelheim
US Army
Chinese Patent Office
Argus Health

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