Data-driven Intelligence on the FDA

OXYCODONE HYDROCHLORIDE - SOLUTION; ORAL

OXYCODONE HYDROCHLORIDE (oxycodone hydrochloride) is made by LEHIGH VALLEY.

Attribute Value
Drug Names(s) OXYCODONE HYDROCHLORIDE - website >
FDA Application No (NDA) 200535
Active Ingredient(s)OXYCODONE HYDROCHLORIDE
CompanyLEHIGH VALLEY
Chemical Type
Review ClassificationS Standard review drug
Products on Application (NDA) 200535
DrugnameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE Code
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION; ORALPrescriptionYes
Approval History
Action DateSupplement NumberActionDocumentsNote
Jan 25, 2012004Labeling Revision-
Oct 20, 2010000Approval-
Patents
Application NoProduct NoExpiration DatePatentNoDS ClaimDP ClaimCodeDefinition
No patent information found.
Exclusivity
Application NoProduct NoExpiration DateCodeDefinition
No exclusivity information found.