FDA.reportPublic FDA data

Application 211487

Type
ANDA
Sponsor
ASCENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;2.5MGNoNo
002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;5MGNoNo
003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;7.5MGNoNo
004HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-940Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-940Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-940Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-940Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-940Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-940Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-941Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-941Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-941Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-941Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-941Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-942Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-942Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-942Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-942Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-942Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-942Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-943Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-943Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-943Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-943Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-943Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-996Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-996Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-996Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-997Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-997Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
31722-997Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenCamber Pharmaceuticals, Inc.ANDACurrent
55700-771Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenQuality Care Products, LLCANDACurrent
55700-771Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenQuality Care Products, LLCANDACurrent
55700-771Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenQuality Care Products, LLCANDACurrent
55700-771Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenQuality Care Products, LLCANDACurrent
55700-781Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenQuality Care Products, LLCANDACurrent
55700-781Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenQuality Care Products, LLCANDACurrent
55700-781Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenQuality Care Products, LLCANDACurrent
55700-781Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenQuality Care Products, LLCANDACurrent
55700-823Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenQuality Care Products, LLCANDACurrent
55700-823Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenQuality Care Products, LLCANDACurrent
55700-823Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenQuality Care Products, LLCANDACurrent
67296-1415Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1415Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1415Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1415Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1425Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1695Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1695Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1695Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1695Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1705Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1705Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1794Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1794Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1794Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
68071-2668Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2857Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
71205-660Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenProficient Rx LPANDACurrent
71335-2103Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-2104Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-2105Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-2112Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-2115Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-2117Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-2118Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-2195Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-9602Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
72189-343HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENDirect RxANDACurrent
72189-343HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENDirect RxANDACurrent
72189-343HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENDirect RxANDACurrent
72189-343HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENDirect RxANDACurrent
72189-343HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENDirect RxANDACurrent
72189-343HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENDirect RxANDACurrent
72189-343HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENDirect RxANDACurrent
72189-348HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENDirectRxANDACurrent
72189-348HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENDirectRxANDACurrent
72189-348HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENDirectRxANDACurrent
72189-348HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENDirectRxANDACurrent
72189-348HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENDirectRxANDACurrent
72189-352Hydrocodone APAPHydrocodone APAPDirect_RxANDACurrent
72189-352Hydrocodone APAPHydrocodone APAPDirect_RxANDACurrent
72189-352Hydrocodone APAPHydrocodone APAPDirect_RxANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76426ORIG 2023-11-07