FDA.reportPublic FDA data

Application 204979

Type
ANDA
Sponsor
ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDESOLUTION;ORAL5MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62559-151Oxycodone HydrochlorideOxycodone HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
62559-151Oxycodone HydrochlorideOxycodone HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
62559-151Oxycodone HydrochlorideOxycodone HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
62559-151Oxycodone HydrochlorideOxycodone HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
62559-151Oxycodone HydrochlorideOxycodone HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
63629-2104Oxycodone HydrochlorideOxycodone HydrochlorideBryant Ranch PrepackANDACurrent
63629-2104Oxycodone HydrochlorideOxycodone HydrochlorideBryant Ranch PrepackANDACurrent
63629-2104Oxycodone HydrochlorideOxycodone HydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76045ORIG 2023-11-02
10411ORIG2015-06-03