Details for New Drug Application (NDA): 085055
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. 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 is one drug master file entry for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.
The generic ingredient in TYLENOL W/ CODEINE NO. 4 is acetaminophen; codeine phosphate. There is one drug master file entry for this compound. Twenty-four 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 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 300MG;7.5MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 300MG;15MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 300MG;30MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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