FDA.reportPublic FDA data

Application 088629

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATETABLET;ORAL300MG;60MGNoYes
002ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATETABLET;ORAL300MG;15MGNoNo
003ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATETABLET;ORAL300MG;30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-0350Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0350Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0350Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0350Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0350Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0350Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0350Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0350Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateTeva Pharmaceuticals USA, Inc.ANDACurrent
42254-145Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateRebel Distributors CorpANDACurrent
61919-273ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEDirectRXANDACurrent
68788-9736Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphatePreferred Pharmaceuticals Inc.ANDACurrent
68788-9736Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphatePreferred Pharmaceuticals Inc.ANDACurrent
70518-1592Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateREMEDYREPACK INC.ANDACurrent
70518-1592Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateREMEDYREPACK INC.ANDACurrent
70518-1592Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateREMEDYREPACK INC.ANDACurrent
71335-0701Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateBryant Ranch PrepackANDACurrent
71335-0701Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateBryant Ranch PrepackANDACurrent
71335-0701Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76106ORIG 2023-11-02