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Last Updated: July 12, 2020

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Details for New Drug Application (NDA): 078769

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NDA 078769 describes OXYCODONE HYDROCHLORIDE AND IBUPROFEN, which is a drug marketed by Actavis Elizabeth, Barr Labs Inc, and Watson Labs, and is included in three NDAs. It is available from one supplier. Additional details are available on the OXYCODONE HYDROCHLORIDE AND IBUPROFEN profile page.

The generic ingredient in OXYCODONE HYDROCHLORIDE AND IBUPROFEN is ibuprofen; oxycodone hydrochloride. There are sixty-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ibuprofen; oxycodone hydrochloride profile page.
Summary for 078769
Pharmacology for NDA: 078769
Suppliers and Packaging for NDA: 078769
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE HYDROCHLORIDE AND IBUPROFEN ibuprofen; oxycodone hydrochloride TABLET;ORAL 078769 ANDA Actavis Pharma, Inc. 0228-4029 0228-4029-11 100 TABLET, FILM COATED in 1 BOTTLE (0228-4029-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG;5MG
Approval Date:Jan 4, 2008TE:RLD:No

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