FDA.reportPublic FDA data

Application 210175

Type
ANDA
Sponsor
ASCENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDETABLET;ORAL5MGNoNo
002OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-929OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDECamber Pharmaceuticals, IncANDACurrent
31722-929OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDECamber Pharmaceuticals, IncANDACurrent
31722-929OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDECamber Pharmaceuticals IncANDACurrent
31722-930OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDECamber Pharmaceuticals, IncANDACurrent
31722-930OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDECamber Pharmaceuticals, IncANDACurrent
31722-930OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDECamber Pharmaceuticals IncANDACurrent
63629-1925OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-1925OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-1926OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-1926OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
72865-130OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDEXLCare Pharmaceuticals, Inc.ANDACurrent
72865-131OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDEXLCare Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76061ORIG 2023-11-02