Details for New Drug Application (NDA): 085056
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NDA 085056 describes TYLENOL W/ CODEINE, which is a drug marketed by Ortho Mcneil Pharm and Janssen Pharms and is included in five NDAs. Additional details are available on the TYLENOL W/ CODEINE profile page.
The generic ingredient in TYLENOL W/ CODEINE is acetaminophen; codeine phosphate. There are sixty-six drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.
The generic ingredient in TYLENOL W/ CODEINE is acetaminophen; codeine phosphate. There are sixty-six drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.
Summary for 085056
| Tradename: | TYLENOL W/ CODEINE |
| Applicant: | Ortho Mcneil Pharm |
| Ingredient: | acetaminophen; codeine phosphate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| 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| Dosage: | TABLET;ORAL | Strength | 325MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 325MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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