FDA.report

Application 040432

Type
ANDA
Sponsor
ANDA REPOSITORY

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;7.5MGNoNo

NDC Listings For This Application

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

DocumentSubmission typeDate
76120ORIG 2023-11-03
17782SUPPL2015-10-27
29957SUPPL2015-10-22