FDA.reportPublic FDA data

Application 207509

Type
ANDA
Sponsor
WES PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL300MG;5MGNoNo
002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL300MG;7.5MGNoNo
003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL300MG;10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63629-1177hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenBryant Ranch PrepackANDACurrent
63629-1177hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenBryant Ranch PrepackANDACurrent
63629-1179hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenBryant Ranch PrepackANDACurrent
63629-1179hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenBryant Ranch PrepackANDACurrent
63629-1180hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenBryant Ranch PrepackANDACurrent
63629-1180hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenBryant Ranch PrepackANDACurrent
63629-1181hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenBryant Ranch PrepackANDACurrent
63629-1181hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenBryant Ranch PrepackANDACurrent
63629-1183hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenBryant Ranch PrepackANDACurrent
63629-1183hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenBryant Ranch PrepackANDACurrent
63629-1184hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenBryant Ranch PrepackANDACurrent
63629-1184hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenBryant Ranch PrepackANDACurrent
71930-042hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenEywa Pharma IncANDACurrent
71930-042hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenEywa Pharma IncANDACurrent
71930-042hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenEywa Pharma IncANDACurrent
71930-043hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenEywa Pharma IncANDACurrent
71930-043hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenEywa Pharma IncANDACurrent
71930-043hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenEywa Pharma IncANDACurrent
71930-044hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenEywa Pharma IncANDACurrent
71930-044hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenEywa Pharma IncANDACurrent
71930-044hydrocodone bitartrate and acetaminophenhydrocodone bitartrate and acetaminophenEywa Pharma IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76425ORIG 2023-11-07