FDA.reportPublic FDA data

Application 209036

Type
ANDA
Sponsor
ABHAI LLC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10702-192Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenKVK-Tech, Inc.ANDACurrent
10702-192Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenKVK-Tech, Inc.ANDACurrent
10702-192Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenKVK-Tech, Inc.ANDACurrent
10702-192Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenKVK-Tech, Inc.ANDACurrent
10702-193Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenKVK-Tech, Inc.ANDACurrent
10702-193Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenKVK-Tech, Inc.ANDACurrent
10702-193Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenKVK-Tech, Inc.ANDACurrent
10702-193Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenKVK-Tech, Inc.ANDACurrent
10702-194Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenKVK-Tech, Inc.ANDACurrent
10702-194Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenKVK-Tech, Inc.ANDACurrent
10702-194Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenKVK-Tech, Inc.ANDACurrent
10702-194Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenKVK-Tech, Inc.ANDACurrent
70518-3491Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76060ORIG 2023-11-02