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

Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Federal Trade Commission
Healthtrust
Mallinckrodt
Moodys
US Department of Justice
Julphar
Fish and Richardson
Chubb

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 085055

« Back to Dashboard

NDA 085055 describes TYLENOL W/ CODEINE NO. 4, which is a drug marketed by Ortho Mcneil Pharm and Janssen Pharms and is included in two NDAs. It is available from three suppliers. Additional details are available on the TYLENOL W/ CODEINE NO. 4 profile page.

The generic ingredient in TYLENOL W/ CODEINE NO. 4 is acetaminophen; codeine phosphate. There are sixty-six drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.
Summary for 085055
Tradename:TYLENOL W/ CODEINE NO. 4
Applicant:Janssen Pharms
Ingredient:acetaminophen; codeine phosphate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 085055
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 085055
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TYLENOL W/ CODEINE NO. 1 acetaminophen; codeine phosphate TABLET;ORAL 085055 ANDA A-S Medication Solutions 50090-0006 N 50090-0006-2
TYLENOL W/ CODEINE NO. 1 acetaminophen; codeine phosphate TABLET;ORAL 085055 ANDA Janssen Pharmaceuticals, Inc. 50458-513 N 50458-513-60

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength300MG;7.5MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength300MG;15MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG;30MG
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:No

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Federal Trade Commission
Express Scripts
Cipla
Julphar
QuintilesIMS
Argus Health
Cerilliant
Covington

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.