FDA.reportPublic FDA data

Application 087508

Type
ANDA
Sponsor
PHARM ASSOC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATESOLUTION;ORAL120MG/5ML;12MG/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0504Acetaminophen and Codeine PhosphateACETAMINOPHEN and CODEINE PHOSPHATEPharmaceutical Associates, Inc.ANDACurrent
21695-547Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateRebel Distributors Corp.ANDACurrent
33261-470Acetaminophen and Codeine PhosphateACETAMINOPHEN and CODEINE PHOSPHATEAidarex Pharmaceuticals LLCANDACurrent
50090-0215Acetaminophen and Codeine PhosphateACETAMINOPHEN and CODEINE PHOSPHATEA-S Medication SolutionsANDACurrent
50090-0215Acetaminophen and Codeine PhosphateACETAMINOPHEN and CODEINE PHOSPHATEA-S Medication SolutionsANDACurrent
50090-0215Acetaminophen and Codeine PhosphateACETAMINOPHEN and CODEINE PHOSPHATEA-S Medication SolutionsANDACurrent
53002-3410Acetaminophen and Codeine PhosphateACETAMINOPHEN and CODEINE PHOSPHATERPK Pharmaceuticals, Inc.ANDACurrent
53002-3410Acetaminophen and Codeine PhosphateACETAMINOPHEN and CODEINE PHOSPHATERPK Pharmaceuticals, Inc.ANDACurrent
63187-291Acetaminophen and Codeine PhosphateACETAMINOPHEN and CODEINE PHOSPHATEProficient Rx LPANDACurrent
63187-291Acetaminophen and Codeine PhosphateACETAMINOPHEN and CODEINE PHOSPHATEProficient Rx LPANDACurrent
66267-997Acetaminophen and Codeine PhosphateACETAMINOPHEN and CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.ANDACurrent
66267-997Acetaminophen and Codeine PhosphateACETAMINOPHEN and CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76139ORIG 2023-11-03