FDA.reportPublic FDA data

Application 208817

Type
ANDA
Sponsor
HI TECH

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
50383-961Oxycodone HydrochlorideOxycodone HydrochlorideAkornANDACurrent
50383-961Oxycodone HydrochlorideOxycodone HydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-961Oxycodone HydrochlorideOxycodone HydrochlorideAkornANDACurrent
50383-961Oxycodone HydrochlorideOxycodone HydrochlorideAkornANDACurrent
50383-961Oxycodone HydrochlorideOxycodone HydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76074ORIG 2023-11-02