FDA.reportPublic FDA data

Application 202800

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

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
0615-8102Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8102Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
13107-058Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAurolife Pharma, LLCANDACurrent
13107-058Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAurolife Pharma, LLCANDACurrent
13107-058Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAurolife Pharma, LLCANDACurrent
13107-058Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAurolife Pharma, LLCANDACurrent
13107-059Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAurolife Pharma, LLCANDACurrent
13107-059Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAurolife Pharma, LLCANDACurrent
13107-059Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAurolife Pharma, LLCANDACurrent
13107-059Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAurolife Pharma, LLCANDACurrent
13107-060Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAurolife Pharma, LLCANDACurrent
13107-060Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAurolife Pharma, LLCANDACurrent
13107-060Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAurolife Pharma, LLCANDACurrent
13107-060Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAurolife Pharma, LLCANDACurrent
45865-439Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateMedsource PharmaceuticalsANDACurrent
45865-466Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateMedsource PharmaceuticalsANDACurrent
50090-1933Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateA-S Medication SolutionsANDACurrent
50090-1933Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateA-S Medication SolutionsANDACurrent
50090-1933Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateA-S Medication SolutionsANDACurrent
50090-1934Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateA-S Medication SolutionsANDACurrent
50090-1935Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateA-S Medication SolutionsANDACurrent
50090-1935Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateA-S Medication SolutionsANDACurrent
50090-1935Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateA-S Medication SolutionsANDACurrent
51655-808Acetaminophen and CodeineAcetaminophen and CodeineNorthwind PharmaceuticalsANDACurrent
51655-808Acetaminophen and CodeineAcetaminophen and CodeineNorthwind PharmaceuticalsANDACurrent
51655-808Acetaminophen and CodeineAcetaminophen and CodeineNorthwind PharmaceuticalsANDACurrent
52959-446Acetaminophen and Codeineacetaminophen and codeine phosphateH.J. Harkins Company, Inc.ANDACurrent
60687-604Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAmerican Health PackagingANDACurrent
60687-604Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAmerican Health PackagingANDACurrent
60687-615Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAmerican Health PackagingANDACurrent
60687-615Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateAmerican Health PackagingANDACurrent
60760-466Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateSt. Mary's Medical Park PharmacyANDACurrent
61919-053ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEDirect_RxANDACurrent
61919-053ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEDIRECT RXANDACurrent
61919-053ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEDirect_RxANDACurrent
61919-053ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEDirect_RxANDACurrent
61919-053ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEDirect_RxANDACurrent
61919-053ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEDIRECT RXANDACurrent
61919-905ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDirect_RxANDACurrent
61919-905ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDirect_RxANDACurrent
63187-815Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateProficient Rx LPANDACurrent
63187-815Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateProficient Rx LPANDACurrent
63187-815Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateProficient Rx LPANDACurrent
63187-815Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateProficient Rx LPANDACurrent
63187-815Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateProficient Rx LPANDACurrent
63629-7668Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateBryant Ranch PrepackANDACurrent
63629-7668Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateBryant Ranch PrepackANDACurrent
67046-929Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateContract Pharmacy Services-PAANDACurrent
67296-1516Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateRedPharm Drug, Inc.ANDACurrent
67296-1516Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateRedPharm Drug, Inc.ANDACurrent
67296-1516Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateRedPharm Drug, Inc.ANDACurrent
68071-3061Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3061Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3061Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3100Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3100Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3100Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3272Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4668Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4668Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4668Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4673Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateNuCare Pharmaceuticals,InANDACurrent
68071-4673Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4673Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4673Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4673Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4749Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4749Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4749Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5010Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5010Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5010Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5025Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5025Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9229Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9229Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9229Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9229Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9229Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9300Acetaminophen and Codeine PhosphateAcetaminophen and Codeine PhosphatePreferred Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76333ORIG 2023-11-03