FDA.reportPublic FDA data

Application 207171

Type
ANDA
Sponsor
LANNETT CO INC

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
0527-1646Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1646Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1646Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1646Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1647Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1647Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1647Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1647Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1648Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1648Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1648Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1648Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76099ORIG 2023-11-02