Details for New Drug Application (NDA): 085057
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NDA 085057 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 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 suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.
Summary for 085057
| 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: | SOLUTION;ORAL | Strength | 120MG/5ML;12MG/5ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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