FDA.reportPublic FDA data

Application 209924

Type
ANDA
Sponsor
NOSTRUM LABS 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
64850-630Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-630Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-630Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-630Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-631Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-631Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-631Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-631Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-632Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-632Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-632Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-632Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-633Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-633Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-633Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent
64850-633Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenElite Laboratories, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76429ORIG 2023-11-07