FDA.reportPublic FDA data

Application 202321

Type
ANDA
Sponsor
SPECGX LLC

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
0406-1009OXYMORPHONE HYDROCHLORIDEOxymorphone HydrochlorideSpecGx LLCANDACurrent
0406-1009OXYMORPHONE HYDROCHLORIDEOxymorphone HydrochlorideSpecGx LLCANDACurrent
0406-1009OXYMORPHONE HYDROCHLORIDEOxymorphone HydrochlorideSpecGx LLCANDACurrent
0406-1009OXYMORPHONE HYDROCHLORIDEOxymorphone HydrochlorideSpecGx LLCANDACurrent
0406-1010OXYMORPHONE HYDROCHLORIDEOxymorphone HydrochlorideSpecGx LLCANDACurrent
0406-1010OXYMORPHONE HYDROCHLORIDEOxymorphone HydrochlorideSpecGx LLCANDACurrent
0406-1010OXYMORPHONE HYDROCHLORIDEOxymorphone HydrochlorideSpecGx LLCANDACurrent
0406-1010OXYMORPHONE HYDROCHLORIDEOxymorphone HydrochlorideSpecGx LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76184ORIG 2023-11-03