APPLICATION
ANDA203107
TYPE
ANDA
ORIGINAL APPROVAL
2012-07-26
LATEST ACTION
2018-09-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
OXYCODONE HYDROCHLORIDEDiscontinued
OXYCODONE HYDROCHLORIDE 5MG · CAPSULE · ORAL
Approval history
2018-09-18REMS · Supplement 2AP
2017-06-29Labeling · Supplement 1 · standardAP
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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