APPLICATION
ANDA078394
TYPE
ANDA
ORIGINAL APPROVAL
2007-11-26
LATEST ACTION
2019-05-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
OXYCODONE HYDROCHLORIDE AND IBUPROFENDiscontinued
IBUPROFEN 400MG, OXYCODONE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2019-05-24Labeling · Supplement 14 · standardAP
2018-09-21Labeling · Supplement 16 · standardAP
2018-09-18REMS · Supplement 15AP
2016-12-16Labeling · Supplement 12 · standardAP
2016-12-16Labeling · Supplement 10 · standardAP
2016-12-16Labeling · Supplement 13 · standardAP
2016-12-16Labeling · Supplement 11 · standardAP
2007-11-26OriginalAP
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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