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FDA ANDA · ANDA088790

TYLOX

Sponsor: JANSSEN PHARMS

APPLICATION
ANDA088790
TYPE
ANDA
ORIGINAL APPROVAL
1984-12-12
LATEST ACTION
2002-07-31
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

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

Approval history

2002-07-31Manufacturing (CMC) · Supplement 15AP
2002-07-31Manufacturing (CMC) · Supplement 14AP
2001-11-30Manufacturing (CMC) · Supplement 16AP
2001-01-24Manufacturing (CMC) · Supplement 12AP
1998-04-03Manufacturing (CMC) · Supplement 11AP
1997-01-06Manufacturing (CMC) · Supplement 10AP
1996-03-25Manufacturing (CMC) · Supplement 9AP
1991-05-30Labeling · Supplement 8AP
1984-12-12OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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