FDA.reportPublic FDA data

Application 205177

Type
ANDA
Sponsor
ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDECAPSULE;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62559-167Oxycodone HydrochlorideOxycodone HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
62559-167Oxycodone HydrochlorideOxycodone HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
62559-167Oxycodone HydrochlorideOxycodone HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
62559-167Oxycodone HydrochlorideOxycodone HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76048ORIG 2023-11-02
32644ORIG2016-04-04