.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 087463

« Back to Dashboard
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-five drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.

Summary for NDA: 087463

Tradename:
OXYCET
Applicant:
Mallinckrodt
Ingredient:
acetaminophen; oxycodone hydrochloride
Patents:0
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 0406-0512-05 500 TABLET in 1 BOTTLE (0406-0512-05)

Summary for product number 001

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


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

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.

`abc