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Last Updated: August 14, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 085055

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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 one supplier. 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. Thirty-four suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.
Summary for 085055
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 50090-0006-2 20 TABLET in 1 BOTTLE (50090-0006-2)
TYLENOL W/ CODEINE NO. 2 acetaminophen; codeine phosphate TABLET;ORAL 085055 ANDA A-S Medication Solutions 50090-0006 50090-0006-2 20 TABLET in 1 BOTTLE (50090-0006-2)

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

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