FDA.reportPublic FDA data

Application 040779

Type
ANDA
Sponsor
AMNEAL PHARMS NY

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43353-010Acetaminophen and CodeineAcetaminophen and CodeineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-010Acetaminophen and CodeineAcetaminophen and CodeineAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-1572Acetaminophen and CodeineAcetaminophen and CodeineA-S Medication SolutionsANDACurrent
50090-1572Acetaminophen and CodeineAcetaminophen and CodeineA-S Medication SolutionsANDACurrent
50090-1573Acetaminophen and CodeineAcetaminophen and CodeineA-S Medication SolutionsANDACurrent
50090-1574Acetaminophen and CodeineAcetaminophen and CodeineA-S Medication SolutionsANDACurrent
50436-3227Acetaminophen and CodeineAcetaminophen and CodeineUnit Dose ServicesANDACurrent
51655-802ACETAMINOPHEN AND CODEINECodeine Phosphate and APAPNorthwind Pharmaceuticals, LLCANDACurrent
53002-0101Acetaminophen and CodeineAcetaminophen and CodeineRPK Pharmaceuticals, Inc.ANDACurrent
53002-0101Acetaminophen and CodeineAcetaminophen and CodeineRPK Pharmaceuticals, Inc.ANDACurrent
61919-023ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDIRECT RXANDACurrent
61919-023ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDIRECT RXANDACurrent
61919-905ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDirect_RxANDACurrent
63187-491Acetaminophen and CodeineAcetaminophen and CodeineProficient Rx LPANDACurrent
63187-491Acetaminophen and CodeineAcetaminophen and CodeineProficient Rx LPANDACurrent
65162-033Acetaminophen and CodeineAcetaminophen and CodeineAmneal Pharmaceuticals LLCANDACurrent
65162-033Acetaminophen and CodeineAcetaminophen and CodeineAmneal Pharmaceuticals LLCANDACurrent
65162-033Acetaminophen and CodeineAcetaminophen and CodeineAmneal Pharmaceuticals LLCANDACurrent
65162-033Acetaminophen and CodeineAcetaminophen and CodeineAmneal Pharmaceuticals LLCANDACurrent
65162-033Acetaminophen and CodeineAcetaminophen and CodeineAmneal Pharmaceuticals LLCANDACurrent
65162-033Acetaminophen and CodeineAcetaminophen and CodeineAmneal Pharmaceuticals LLCANDACurrent
65162-033Acetaminophen and CodeineAcetaminophen and CodeineAmneal Pharmaceuticals LLCANDACurrent
66267-001Acetaminophen and CodeineAcetaminophen and CodeineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-759Acetaminophen and CodeineAcetaminophen and CodeineNuCare Pharmaceuticals,Inc.ANDACurrent
66267-759Acetaminophen and CodeineAcetaminophen and CodeineNuCare Pharmaceuticals,Inc.ANDACurrent
67046-908Acetaminophen and CodeineAcetaminophen and CodeineContract Pharmacy Services-PAANDACurrent
67296-1772Acetaminophen and CodeineAcetaminophen and CodeineRedPharm Drug, Inc.ANDACurrent
67296-1772Acetaminophen and CodeineAcetaminophen and CodeineRedPharm Drug, Inc.ANDACurrent
68071-3059Acetaminophen and CodeineAcetaminophen and CodeineNuCarePharmaceuticals, Inc.ANDACurrent
68788-9403Acetaminophen and CodeineAcetaminophen and CodeinePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9403Acetaminophen and CodeineAcetaminophen and CodeinePreferred Pharmaceuticals, Inc.ANDACurrent
71335-0545Acetaminophen and CodeineAcetaminophen and CodeineBryant Ranch PrepackANDACurrent
71335-0545Acetaminophen and CodeineAcetaminophen and CodeineBryant Ranch PrepackANDACurrent
71335-0545Acetaminophen and CodeineAcetaminophen and CodeineBryant Ranch PrepackANDACurrent
76420-103Acetaminophen and CodeineAcetaminophen and CodeineAsclemed USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76301ORIG 2023-11-03