FDA.reportPublic FDA data

Application 204037

Type
ANDA
Sponsor
HIKMA

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
0054-0390oxycodone hydrochlorideoxycodone hydrochlorideHikma Pharmceuticals USA Inc.ANDACurrent
0054-0390oxycodone hydrochlorideoxycodone hydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0390oxycodone hydrochlorideoxycodone hydrochlorideHikma Pharmceuticals USA Inc.ANDACurrent
0054-0390oxycodone hydrochlorideoxycodone hydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0390oxycodone hydrochlorideoxycodone hydrochlorideWest-Ward PharmaceuticalsANDACurrent
17856-0390oxycodone hydrochlorideoxycodone hydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0390oxycodone hydrochlorideoxycodone hydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
60687-406Oxycodone HydrochlorideOxycodone HydrochlorideAmerican Health PackagingANDACurrent
60687-406Oxycodone HydrochlorideOxycodone HydrochlorideAmerican Health PackagingANDACurrent
60687-406Oxycodone HydrochlorideOxycodone HydrochlorideAmerican Health PackagingANDACurrent
60687-406Oxycodone HydrochlorideOxycodone HydrochlorideAmerican Health PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76211ORIG 2023-11-03