FDA.reportPublic FDA data

Application 085055

Type
ANDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TYLENOL W/ CODEINE NO. 1ACETAMINOPHEN; CODEINE PHOSPHATETABLET;ORAL300MG;7.5MGNoNo
002TYLENOL W/ CODEINE NO. 2ACETAMINOPHEN; CODEINE PHOSPHATETABLET;ORAL300MG;15MGNoNo
003TYLENOL W/ CODEINE NO. 3ACETAMINOPHEN; CODEINE PHOSPHATETABLET;ORAL300MG;30MGNoYes
004TYLENOL W/ CODEINE NO. 4ACETAMINOPHEN; CODEINE PHOSPHATETABLET;ORAL300MG;60MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-0006TYLENOL with Codeineacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-0006TYLENOL with Codeineacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50458-513TYLENOL with Codeineacetaminophen and codeine phosphateJanssen Pharmaceuticals, Inc.ANDACurrent
50458-513TYLENOL with Codeineacetaminophen and codeine phosphateJanssen Pharmaceuticals, Inc.ANDACurrent
50458-513TYLENOL with Codeineacetaminophen and codeine phosphateJanssen Pharmaceuticals, Inc.ANDACurrent
50458-513TYLENOL with Codeineacetaminophen and codeine phosphateJanssen Pharmaceuticals, Inc.ANDACurrent
50458-513TYLENOL with Codeineacetaminophen and codeine phosphateJanssen Pharmaceuticals, Inc.ANDACurrent
50458-515TYLENOL with Codeineacetaminophen and codeine phosphateJanssen Pharmaceuticals, Inc.ANDACurrent
50458-515TYLENOL with Codeineacetaminophen and codeine phosphateJanssen Pharmaceuticals, Inc.ANDACurrent
50458-515TYLENOL with Codeineacetaminophen and codeine phosphateJanssen Pharmaceuticals, Inc.ANDACurrent
50458-515TYLENOL with Codeineacetaminophen and codeine phosphateJanssen Pharmaceuticals, Inc.ANDACurrent
50458-515TYLENOL with Codeineacetaminophen and codeine phosphateJanssen Pharmaceuticals, Inc.ANDACurrent