APPLICATION
ANDA204085
TYPE
ANDA
ORIGINAL APPROVAL
2014-09-10
LATEST ACTION
2020-11-05
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
OXYCODONE HYDROCHLORIDEDiscontinued
OXYCODONE HYDROCHLORIDE 100MG/5ML · SOLUTION · ORAL
Approval history
2020-11-05Labeling · Supplement 6 · standardAP
2020-11-05Labeling · Supplement 9 · standardAP
2018-09-18REMS · Supplement 4AP
2015-09-25Manufacturing (CMC) · Supplement 1 · unknownAP
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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