FDA.reportPublic FDA data

Application 040482

Type
ANDA
Sponsor
ANDA REPOSITORY

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0713-0703HycetHydrocodone bitartrate and acetaminophenG&W Laboratories, Inc.ANDACurrent
0713-0704Hydrocodone Bitartrate and AcetaminophenHydrocodone bitartrate and acetaminophenG&W Laboratories, Inc.ANDACurrent
46672-642hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-642hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-642hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent
46672-642hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenMikart, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76116ORIG 2023-11-03