FDA.reportPublic FDA data

Application 201013

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;5MGNoNo
002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;7.5MGNoNo
003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13107-019Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAurolife Pharma, LLCANDACurrent
13107-019Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAurolife Pharma LLCANDACurrent
13107-019Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAurolife Pharma LLCANDACurrent
13107-020Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAurolife Pharma, LLCANDACurrent
13107-020Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAurolife Pharma LLCANDACurrent
13107-020Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAurolife Pharma LLCANDACurrent
13107-021Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAurolife Pharma, LLCANDACurrent
13107-021Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAurolife Pharma LLCANDACurrent
13107-021Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAurolife Pharma LLCANDACurrent
35356-795Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-796Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-796Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-797Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-797Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-1084Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenA-S Medication SolutionsANDACurrent
50090-2120Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenA-S Medication SolutionsANDACurrent
50090-2120Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenA-S Medication SolutionsANDACurrent
50090-2120Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenA-S Medication SolutionsANDACurrent
50090-2120Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenA-S Medication SolutionsANDACurrent
50090-2121Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenA-S Medication SolutionsANDACurrent
50090-2121Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenA-S Medication SolutionsANDACurrent
50090-2121Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenA-S Medication SolutionsANDACurrent
50090-2229Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenA-S Medication SolutionsANDACurrent
50090-2229Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenA-S Medication SolutionsANDACurrent
50090-2229Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenA-S Medication SolutionsANDACurrent
50090-3688Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenA-S Medication SolutionsANDACurrent
50090-3689Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenA-S Medication SolutionsANDACurrent
50090-4064Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenA-S Medication SolutionsANDACurrent
51655-804Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNorthwind PharmaceuticalsANDACurrent
51655-898Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNorthwind PharmaceuticalsANDACurrent
52959-324HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENH.J. Harkins Company, Inc.ANDACurrent
52959-735HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENH.J. Harkins Company, Inc.ANDACurrent
53217-265Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAidarex Pharmaceuticals LLCANDACurrent
53217-266Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAidarex Pharmaceuticals LLCANDACurrent
53217-267Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAidarex Pharmaceuticals LLCANDACurrent
60760-218Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenSt. Mary's Medical Park PharmacyANDACurrent
60760-218Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenSt. Mary's Medical Park PharmacyANDACurrent
60760-219Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenSt. Mary's Medical Park PharmacyANDACurrent
60760-220Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenSt. Mary's Medical Park PharmacyANDACurrent
61919-208HYRDROCODONE APAPHYRDROCODONE APAPDirect RxANDACurrent
61919-208HYRDROCODONE APAPHYRDROCODONE APAPDirect_RxANDACurrent
61919-208HYRDROCODONE APAPHYRDROCODONE APAPDirect_RxANDACurrent
61919-208HYRDROCODONE APAPHYRDROCODONE APAPDirect_RxANDACurrent
61919-208HYRDROCODONE APAPHYRDROCODONE APAPDirect_RxANDACurrent
61919-208HYRDROCODONE APAPHYRDROCODONE APAPDirect_RxANDACurrent
61919-618HYDROCODONE /APAPHYDROCODONE /APAPDIRECTRXANDACurrent
61919-618HYDROCODONE /APAPHYDROCODONE /APAPDirect_RxANDACurrent
61919-618HYDROCODONE /APAPHYDROCODONE /APAPDirect_RxANDACurrent
61919-618HYDROCODONE /APAPHYDROCODONE /APAPDirect_RxANDACurrent
61919-618HYDROCODONE /APAPHYDROCODONE /APAPDirect_RxANDACurrent
61919-618HYDROCODONE /APAPHYDROCODONE /APAPDirect_RxANDACurrent
61919-618HYDROCODONE /APAPHYDROCODONE /APAPDirect_RxANDACurrent
61919-618HYDROCODONE /APAPHYDROCODONE /APAPDirect_RxANDACurrent
61919-618HYDROCODONE /APAPHYDROCODONE /APAPDirect_RxANDACurrent
61919-618HYDROCODONE /APAPHYDROCODONE /APAPDirect_RxANDACurrent
61919-618HYDROCODONE /APAPHYDROCODONE /APAPDirect_RxANDACurrent
61919-618HYDROCODONE /APAPHYDROCODONE /APAPDirect_RxANDACurrent
61919-828HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENDirect_RxANDACurrent
61919-828HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENDirect_RxANDACurrent
61919-828HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENDirect_RxANDACurrent
61919-828HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENDirect_RxANDACurrent
63187-375Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenProficient Rx LPANDACurrent
63187-375Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenProficient Rx LPANDACurrent
63187-375Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenProficient Rx LPANDACurrent
63187-375Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenProficient Rx LPANDACurrent
63187-658Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenProficient Rx LPANDACurrent
63187-658Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenProficient Rx LPANDACurrent
63187-658Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenProficient Rx LPANDACurrent
63187-658Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenProficient Rx LPANDACurrent
63187-778Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenProficient Rx LPANDACurrent
63187-778Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenProficient Rx LPANDACurrent
63187-778Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenProficient Rx LPANDACurrent
63187-778Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenProficient Rx LPANDACurrent
63629-7822Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-7822Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
66267-319Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
66267-319Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
67296-1791Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1791Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1791Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76323ORIG 2023-11-03