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Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 087463

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NDA 087463 describes OXYCET, which is a drug marketed by Specgx Llc 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
Applicant:Specgx Llc
Ingredient:acetaminophen; oxycodone hydrochloride
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 SpecGx LLC 0406-0512 N 0406-0512-23
OXYCET acetaminophen; oxycodone hydrochloride TABLET;ORAL 087463 ANDA SpecGx LLC 0406-0512 N 0406-0512-62

Profile for product number 001

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

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