FDA.reportPublic FDA data

Application 040432

Type
ANDA
Sponsor
ANDA REPOSITORY

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43547-373Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenSolco Healthcare US, LLCANDACurrent
43547-373Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenSolco Healthcare US, LLCANDACurrent
46672-147hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-147hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-147hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-147hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-147hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76120ORIG 2023-11-03
17782SUPPL2015-10-27
29957SUPPL2015-10-22