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FDA NDA · NDA022235

LUVOX

Sponsor: JAZZ

APPLICATION
NDA022235
TYPE
NDA
ORIGINAL APPROVAL
2008-04-14
LATEST ACTION
2008-04-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LUVOXPrescription
FLUVOXAMINE MALEATE 25MG · TABLET · ORAL
LUVOXPrescription
FLUVOXAMINE MALEATE 50MG · TABLET · ORAL
LUVOXPrescription
FLUVOXAMINE MALEATE 100MG · TABLET · ORAL

Approval history

2008-04-14Type 6 - New Indication (no longer used) · Original · standard — Other Important Information from FDA ↗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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