FDA.reportPublic FDA data

Application 201187

Type
ANDA
Sponsor
EPIC PHARMA 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
42806-330Oxymorphone HydrochlorideOxymorphone HydrochlorideEpic Pharma, LLCANDACurrent
42806-330Oxymorphone HydrochlorideOxymorphone HydrochlorideEpic Pharma, LLCANDACurrent
42806-331Oxymorphone HydrochlorideOxymorphone HydrochlorideEpic Pharma, LLCANDACurrent
42806-331Oxymorphone HydrochlorideOxymorphone HydrochlorideEpic Pharma, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76324ORIG 2023-11-03