FDA.reportPublic FDA data

Application 211729

Type
ANDA
Sponsor
GRANULES PHARMS

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
70010-672Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenGranules Pharmaceuticals Inc.ANDACurrent
70010-672Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenGranules Pharmaceuticals Inc.ANDACurrent
70010-673Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenGranules Pharmaceuticals Inc.ANDACurrent
70010-673Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenGranules Pharmaceuticals Inc.ANDACurrent
70010-674Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenGranules Pharmaceuticals Inc.ANDACurrent
70010-674Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenGranules Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76452ORIG 2023-11-07