FDA.reportPublic FDA data

Application 040846

Type
ANDA
Sponsor
ANDA REPOSITORY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;2.5MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33261-881Hydrocodone Bitartate and AcetaminophenHYDROCODONE BITARTRATE, ACETAMINOPHENAidarex Pharmaceuticals LLCANDACurrent
42254-300Hydrocodone Bitartate and AcetaminophenHYDROCODONE BITARTRATE, ACETAMINOPHENRebel Distributors CorpANDACurrent
46672-092hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-092hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-092hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-092hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-092hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
63629-5428Hydrocodone Bitartate and AcetaminophenHYDROCODONE BITARTRATE, ACETAMINOPHENBryant Ranch PrepackANDACurrent
76519-1011Hydrocodone Bitartate and AcetaminophenHYDROCODONE BITARTRATE, ACETAMINOPHENH.J. Harkins Company, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
38901SUPPL2015-10-27
29966SUPPL2015-10-22