FDA.reportPublic FDA data

Application 206484

Type
ANDA
Sponsor
UPSHER SMITH LABS

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
0245-0410Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenUpsher-Smith Laboratories, LLCANDACurrent
0245-0410Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenUpsher-Smith Laboratories, LLCANDACurrent
0245-0410Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenUpsher-Smith Laboratories, LLCANDACurrent
0245-0410Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenUpsher-Smith Laboratories, LLCANDACurrent
0245-0410Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenUpsher-Smith Laboratories, LLCANDACurrent
0245-0411Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenUpsher-Smith Laboratories, LLCANDACurrent
0245-0411Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenUpsher-Smith Laboratories, LLCANDACurrent
0245-0411Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenUpsher-Smith Laboratories, LLCANDACurrent
0245-0411Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenUpsher-Smith Laboratories, LLCANDACurrent
0245-0411Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenUpsher-Smith Laboratories, LLCANDACurrent
0245-0412Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenUpsher-Smith Laboratories, LLCANDACurrent
0245-0412Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenUpsher-Smith Laboratories, LLCANDACurrent
0245-0412Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenUpsher-Smith Laboratories, LLCANDACurrent
0245-0412Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenUpsher-Smith Laboratories, LLCANDACurrent
0245-0412Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenUpsher-Smith Laboratories, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76149ORIG 2023-11-03