FDA.reportPublic FDA data

Application 040881

Type
ANDA
Sponsor
MIKART

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATESOLUTION;ORAL300MG/15ML;10MG/15MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-450LortabHydrocodone Bitartrate and AcetaminophenAkorn, Inc.ANDACurrent
17478-450LortabHydrocodone Bitartrate and AcetaminophenAkorn, Inc.ANDACurrent
17478-450LortabHydrocodone Bitartrate and AcetaminophenAkorn, Inc.ANDACurrent
17478-450LortabHydrocodone Bitartrate and AcetaminophenAkornANDACurrent
17478-450LortabHydrocodone Bitartrate and AcetaminophenAkornANDACurrent
17856-0450LortabHydrocodone Bitartrate and AcetaminophenAtlantic Biologicals CorpsANDACurrent
46672-645hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-645hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-645hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-645hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76118ORIG 2023-11-03