FDA.reportPublic FDA data

Application 040099

Type
ANDA
Sponsor
APIL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORCOACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;5MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-6002NorcoHydrocodone Bitartrate and AcetaminophenAllergan, Inc.ANDACurrent
0023-6002NorcoHydrocodone Bitartrate and AcetaminophenAllergan, Inc.ANDACurrent
0023-6002NorcoHydrocodone Bitartrate and AcetaminophenAllergan, Inc.ANDACurrent
0023-6002NorcoHydrocodone Bitartrate and AcetaminophenAllergan, Inc.ANDACurrent
0023-6002NorcoHydrocodone Bitartrate and AcetaminophenAllergan, Inc.ANDACurrent
0904-6419Hydrocodone Bitartate and AcetaminophenHydrocodone Bitartate and AcetaminophenMajor PharmaceuticalsANDACurrent
12634-264HYDROCODONE BITARTRATE AND ACETAMINOPHENhydrocodone bitartrate and acetaminophenApotheca Inc.ANDACurrent
54348-013HYDROCODONE/APAPHYDROCODONE BITARTRATE,PharmPak, Inc.ANDACurrent
68387-236NorcoHydrocodone Bitartrate And AcetaminophenKeltman Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64646SUPPL2020-09-22
64645SUPPL2020-09-22
38867SUPPL2014-12-12
7572SUPPL2014-12-09
22083SUPPL2004-12-08