FDA.reportPublic FDA data

Application 207172

Type
ANDA
Sponsor
LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;5MGNoNo
002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;7.5MGNoNo
003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-1649Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1649Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1649Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1649Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1650Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1650Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1650Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1650Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1651Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1651Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1651Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent
0527-1651Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLannett Company, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76100ORIG 2023-11-02
48830ORIG2017-06-26