FDA.reportPublic FDA data

Application 040834

Type
ANDA
Sponsor
PHARM ASSOC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATESOLUTION;ORAL325MG/15ML;10MG/15MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-1542ZamicetHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0121-2313ZamicetHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0486-0771ZamicetHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
0486-4771ZamicetHYDROCODONE BITARTRATE and ACETAMINOPHENPharmaceutical Associates, Inc.ANDACurrent
69101-600HYDROCODONE BITARTRATE and ACETAMINOPHENHYDROCODONE BITARTRATE and ACETAMINOPHENBurke Therapeutics, LLCANDACurrent
69101-600HYDROCODONE BITARTRATE and ACETAMINOPHENHYDROCODONE BITARTRATE and ACETAMINOPHENBurke Therapeutics, LLCANDACurrent
69101-600HYDROCODONE BITARTRATE and ACETAMINOPHENHYDROCODONE BITARTRATE and ACETAMINOPHENBurke Therapeutics, LLCANDACurrent
79880-600HYDROCODONE BITARTRATE and ACETAMINOPHENHYDROCODONE BITARTRATE and ACETAMINOPHENStrovin Pharmaceuticals, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76142ORIG 2023-11-03
44198ORIG2008-04-25