FDA.reportPublic FDA data

Application 202214

Type
ANDA
Sponsor
TRIS PHARMA 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
004HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL300MG;5MGNoNo
005HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL300MG;7.5MGNoNo
006HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL300MG;10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
27808-035Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-035Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-035Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-035Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-035Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-035Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-036Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-036Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-036Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-036Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-036Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-036Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-037Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-037Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-037Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-037Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-037Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-037Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-114Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-114Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-114Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-114Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-114Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-114Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-114Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-115Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-115Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-115Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-115Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-115Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-115Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-115Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-116Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-116Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-116Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-116Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-116Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-116Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
27808-116Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTris Pharma IncANDACurrent
63629-2292Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2292Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2292Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2293Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2293Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2293Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2294Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2294Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2294Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2295Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2295Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2295Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2296Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2296Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2296Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2297Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2297Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2297Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2298Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2298Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2298Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2299Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2299Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2299Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2300Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2300Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2300Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2308Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2308Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2308Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2309Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2309Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2309Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2310Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2310Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2310Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
67296-1571Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1571Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1571Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1574Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1574Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76147ORIG 2023-11-03