FDA.reportPublic FDA data

Application 211610

Type
ANDA
Sponsor
EYWA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-5198ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-5198ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-5198ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-5200ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-5200ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-5200ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-5201ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-5201ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-5201ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-5204ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-5204ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
63629-1185ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateBryant Ranch PrepackANDACurrent
63629-1185ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateBryant Ranch PrepackANDACurrent
63629-1185ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateBryant Ranch PrepackANDACurrent
63629-1186ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateBryant Ranch PrepackANDACurrent
63629-1187ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateBryant Ranch PrepackANDACurrent
63629-1187ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateBryant Ranch PrepackANDACurrent
63629-1187ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateBryant Ranch PrepackANDACurrent
63629-1188ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateBryant Ranch PrepackANDACurrent
63629-1188ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateBryant Ranch PrepackANDACurrent
63629-1188ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateBryant Ranch PrepackANDACurrent
63629-1188ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateBryant Ranch PrepackANDACurrent
63629-1189ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateBryant Ranch PrepackANDACurrent
63629-1190ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateBryant Ranch PrepackANDACurrent
63629-1190ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateBryant Ranch PrepackANDACurrent
63629-1190ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateBryant Ranch PrepackANDACurrent
68071-2681ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7801ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7801ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7801ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7802ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7802ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7802ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphatePreferred Pharmaceuticals Inc.ANDACurrent
70518-2628ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateREMEDYREPACK INC.ANDACurrent
70518-2628ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateREMEDYREPACK INC.ANDACurrent
70518-2628ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateREMEDYREPACK INC.ANDACurrent
70518-2764ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateREMEDYREPACK INC.ANDACurrent
70518-2764ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateREMEDYREPACK INC.ANDACurrent
70518-2764ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateREMEDYREPACK INC.ANDACurrent
71335-1818ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateBryant Ranch PrepackANDACurrent
71335-1846ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateBryant Ranch PrepackANDACurrent
71930-054ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateEywa Pharma IncANDACurrent
71930-054ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateEywa Pharma IncANDACurrent
71930-055ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateEywa Pharma IncANDACurrent
71930-055ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateEywa Pharma IncANDACurrent
71930-056ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateEywa Pharma IncANDACurrent
71930-056ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateEywa Pharma IncANDACurrent