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FDA ANDA · ANDA040061

ROXILOX

Sponsor: ROXANE

APPLICATION
ANDA040061
TYPE
ANDA
ORIGINAL APPROVAL
1995-07-03
LATEST ACTION
2001-08-14
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

ROXILOXDiscontinued
ACETAMINOPHEN 500MG, OXYCODONE HYDROCHLORIDE 5MG · CAPSULE · ORAL

Approval history

2001-08-14Labeling · Supplement 8AP
2001-04-26Manufacturing (CMC) · Supplement 7AP
2001-04-26Manufacturing (CMC) · Supplement 6AP
1999-04-22Manufacturing (CMC) · Supplement 4AP
1999-03-19Manufacturing (CMC) · Supplement 3AP
1999-03-19Manufacturing (CMC) · Supplement 2AP
1996-08-28Manufacturing (CMC) · Supplement 1AP
1995-07-03OriginalAP
VIEW ON DRUGS@FDA ↗

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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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