FDA.reportPublic FDA data

Application 040148

Type
ANDA
Sponsor
APIL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORCOACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;10MGNoYes
002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL500MG;10MGNoNo
003NORCOACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;7.5MGNoYes
004NORCOACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;2.5MGNoNo
005NORCOACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-6021NorcoHydrocodone Bitartrate and AcetaminophenAllergan, Inc.ANDACurrent
0023-6021NorcoHydrocodone Bitartrate and AcetaminophenAllergan, Inc.ANDACurrent
0023-6021NorcoHydrocodone Bitartrate and AcetaminophenAllergan, Inc.ANDACurrent
0023-6021NorcoHydrocodone Bitartrate and AcetaminophenAllergan, Inc.ANDACurrent
0023-6021NorcoHydrocodone Bitartrate and AcetaminophenAllergan, Inc.ANDACurrent
0023-6022NorcoHydrocodone Bitartrate and AcetaminophenAllergan, Inc.ANDACurrent
0023-6022NorcoHydrocodone Bitartrate and AcetaminophenAllergan, Inc.ANDACurrent
0023-6022NorcoHydrocodone Bitartrate and AcetaminophenAllergan, Inc.ANDACurrent
0023-6022NorcoHydrocodone Bitartrate and AcetaminophenAllergan, Inc.ANDACurrent
0023-6022NorcoHydrocodone Bitartrate and AcetaminophenAllergan, Inc.ANDACurrent
0591-2171Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenActavis Pharma, Inc.ANDACurrent
0591-2171Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenActavis Pharma, Inc.ANDACurrent
0591-2172Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenActavis Pharma, Inc.ANDACurrent
0591-2172Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenActavis Pharma, Inc.ANDACurrent
0591-2605Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenActavis Pharma, Inc.ANDACurrent
0591-2605Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenActavis Pharma, Inc.ANDACurrent
0591-2612Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenActavis Pharma, Inc.ANDACurrent
0591-2612Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenActavis Pharma, Inc.ANDACurrent
0904-6420Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenMajor PharmaceuticalsANDACurrent
0904-6420Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenMajor PharmaceuticalsANDACurrent
0904-6421Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenMajor PharmaceuticalsANDACurrent
0904-6421Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenMajor PharmaceuticalsANDACurrent
0904-6567Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenMajor PharmaceuticalsANDACurrent
0904-6567Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenMajor PharmaceuticalsANDACurrent
50436-2171Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenUnit Dose ServicesANDACurrent
50436-2605Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenUnit Dose ServicesANDACurrent
50436-2612Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenUnit Dose ServicesANDACurrent
52544-071NorcoHydrocodone Bitatrate and AcetaminophenActavis Pharma, Inc.ANDACurrent
52544-161NorcoHydrocodone Bitatrate and AcetaminophenActavis Pharma, Inc.ANDACurrent
52544-162NorcoHydrocodone Bitatrate and AcetaminophenActavis Pharma, Inc.ANDACurrent
53217-192Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAidarex Pharmaceuticals LLCANDACurrent
55700-216Hydrocodone Bitatrate and AcetaminophenHydrocodone Bitatrate and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
63187-838Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenProficient Rx LPANDACurrent
63187-838Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenProficient Rx LPANDACurrent
65084-288NorcoHydrocodone Bitatrate and AcetaminophenMckesson Rxpak IncANDACurrent
65084-453Hydrocodone Bitatrate and AcetaminophenHydrocodone Bitatrate and AcetaminophenMckesson Rxpak IncANDACurrent
68084-884Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmerican Health PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64644SUPPL2020-09-22
17750SUPPL2015-11-04
7573SUPPL2015-10-22
42588SUPPL2005-07-22
42587SUPPL2005-07-22
42586SUPPL2005-07-22
22087SUPPL2005-07-22
22086SUPPL2005-07-22