FDA.reportPublic FDA data

Application 206142

Type
ANDA
Sponsor
NOVEL LABS 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
40032-351Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNovel Laboratories, Inc.ANDACurrent
40032-351Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNovel Laboratories, Inc.ANDACurrent
40032-352Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNovel Laboratories, Inc.ANDACurrent
40032-352Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNovel Laboratories, Inc.ANDACurrent
40032-353Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNovel Laboratories, Inc.ANDACurrent
40032-353Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNovel Laboratories, Inc.ANDACurrent
43386-351Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent
43386-351Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent
43386-351Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent
43386-352Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent
43386-352Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent
43386-352Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent
43386-353Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent
43386-353Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent
43386-353Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76132ORIG 2023-11-03