APPLICATION
ANDA076168
TYPE
ANDA
LATEST ACTION
2004-05-25
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
None (Tentative Approval)
Products
OXYCODONE HYDROCHLORIDENone (Tentative Approval)
OXYCODONE HYDROCHLORIDE 80MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2004-05-25Labeling · Supplement 2AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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