Application 207511

Type
ANDA
Sponsor
EYWA

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
0904-6678Oxycodone HydrochlorideOxycodone HydrochlorideMAJOR PHARMACEUTICALSANDACurrent
0904-6678Oxycodone HydrochlorideOxycodone HydrochlorideMAJOR PHARMACEUTICALSANDACurrent
0904-6678Oxycodone HydrochlorideOxycodone HydrochlorideMAJOR PHARMACEUTICALSANDACurrent
0904-6828Oxycodone HydrochlorideOxycodone HydrochlorideMAJOR PHARMACEUTICALSANDACurrent
0904-6828Oxycodone HydrochlorideOxycodone HydrochlorideMAJOR PHARMACEUTICALSANDACurrent
0904-6828Oxycodone HydrochlorideOxycodone HydrochlorideMAJOR PHARMACEUTICALSANDACurrent
0904-6828Oxycodone HydrochlorideOxycodone HydrochlorideMAJOR PHARMACEUTICALSANDACurrent
0904-6828Oxycodone HydrochlorideOxycodone HydrochlorideMAJOR PHARMACEUTICALSANDACurrent
0904-6828Oxycodone HydrochlorideOxycodone HydrochlorideMAJOR PHARMACEUTICALSANDACurrent
63629-1174Oxycodone HydrochlorideOxycodone HydrochlorideBryant Ranch PrepackANDACurrent
63629-1174Oxycodone HydrochlorideOxycodone HydrochlorideBryant Ranch PrepackANDACurrent
63629-1174Oxycodone HydrochlorideOxycodone HydrochlorideBryant Ranch PrepackANDACurrent
71930-022Oxycodone HydrochlorideOxycodone HydrochlorideEywa Pharma IncANDACurrent
71930-022Oxycodone HydrochlorideOxycodone HydrochlorideEywa Pharma IncANDACurrent
71930-022Oxycodone HydrochlorideOxycodone HydrochlorideEywa Pharma IncANDACurrent
71930-022Oxycodone HydrochlorideOxycodone HydrochlorideEywa Pharma IncANDACurrent
71930-022Oxycodone HydrochlorideOxycodone HydrochlorideEywa Pharma IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76202ORIG 2023-11-03