FDA.reportPublic FDA data

Application 040658

Type
ANDA
Sponsor
MIKART

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL300MG;5MGNoYes
002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL300MG;7.5MGNoYes
003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL300MG;10MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-3041VicodinHydrocodone Bitartrate and AcetaminophenAbbVie Inc.ANDACurrent
0074-3043VicodinHydrocodone Bitartrate and AcetaminophenAbbVie Inc.ANDACurrent
0074-3054VicodinHydrocodone Bitartrate and AcetaminophenAbbVie Inc.ANDACurrent
21695-773XodolHydrocodone Bitartrate and AcetaminophenRebel Distributors Corp.ANDACurrent
42254-291Xodolhydrocodone bitartrate and acetaminophenRebel Distributors CorpANDACurrent
46672-036hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-036hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-036hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-036hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-036hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-166hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-166hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-166hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-166hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-166hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-192hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-192hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-192hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-192hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-192hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76117ORIG 2023-11-03
38898SUPPL2015-10-27
7675SUPPL2015-10-22