Application 209897

Type
ANDA
Sponsor
EYWA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDESOLUTION;ORAL100MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6701Oxycodone HydrochlorideOxycodone HydrochlorideMajor PharmaceuticalsANDACurrent
71930-023Oxycodone HydrochlorideOxycodone hydrochlorideEywa Pharma IncANDACurrent
71930-023Oxycodone HydrochlorideOxycodone hydrochlorideEywa Pharma IncANDACurrent
71930-023Oxycodone HydrochlorideOxycodone hydrochlorideEywa Pharma IncANDACurrent
71930-023Oxycodone HydrochlorideOxycodone hydrochlorideEywa Pharma IncANDACurrent
71930-023Oxycodone HydrochlorideOxycodone hydrochlorideEywa Pharma IncANDACurrent
71930-023Oxycodone HydrochlorideOxycodone hydrochlorideEywa Pharma IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76203ORIG 2023-11-03
49703ORIG2017-09-08