FDA.reportPublic FDA data

Application 206245

Type
ANDA
Sponsor
NOVEL LABS 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
0904-6824Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenMajor PharmaceuticalsANDACurrent
0904-6824Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenMajor PharmaceuticalsANDACurrent
0904-6824Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenMajor PharmaceuticalsANDACurrent
0904-6825Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenMajor PharmaceuticalsANDACurrent
0904-6825Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenMajor PharmaceuticalsANDACurrent
0904-6825Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenMajor PharmaceuticalsANDACurrent
0904-6826Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenMajor PharmaceuticalsANDACurrent
0904-6826Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenMajor PharmaceuticalsANDACurrent
0904-6826Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenMajor PharmaceuticalsANDACurrent
40032-356Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNovel Laboratories, Inc.ANDACurrent
40032-356Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNovel Laboratories, Inc.ANDACurrent
40032-357Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNovel Laboratories, Inc.ANDACurrent
40032-357Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNovel Laboratories, Inc.ANDACurrent
40032-358Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNovel Laboratories, Inc.ANDACurrent
40032-358Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNovel Laboratories, Inc.ANDACurrent
43386-356Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent
43386-356Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent
43386-356Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent
43386-357Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent
43386-357Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent
43386-357Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent
43386-358Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent
43386-358Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent
43386-358Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLupin Pharmaceuticals,Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76133ORIG 2023-11-03