← FDA DRUG APPROVALS

FDA NDA · NDA021693

RYBIX ODT

Sponsor: SHIONOGI INC

APPLICATION
NDA021693
TYPE
NDA
ORIGINAL APPROVAL
2005-05-05
LATEST ACTION
2010-08-13
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued

Products

RYBIX ODTDiscontinued
TRAMADOL HYDROCHLORIDE 50MG · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2010-08-13Labeling · Supplement 2 · unknown — Letter ↗AP
2010-06-25Labeling · Supplement 4 · unknown — Letter ↗AP
2006-07-12Manufacturing (CMC) · Supplement 1 — Letter ↗AP
2005-05-05Type 3 - New Dosage Form · Original · standard — Label ↗AP
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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