FDA.reportPublic FDA data

Application 040838

Type
ANDA
Sponsor
PHARM ASSOC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATESOLUTION;ORAL325MG/15ML;7.5MG/15MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-0772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-0772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-0772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-0772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-0772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-0772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-1544Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-1544Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-1544Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-1544Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-1544Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-1544Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-1544Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-2316Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-2316Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-2316Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-2316Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-2316Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-2316Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-2316Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-4772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-4772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-4772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-4772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-4772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-4772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-4772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
12634-616Hydrocodone Bitartrate and Acetaminophenhydrocodone bitartrate and acetaminophenApotheca, IncANDACurrent
68788-6352Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHENPreferred Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76140ORIG 2023-11-03