← FDA DRUG APPROVALS

FDA NDA · NDA022033

LUVOX CR

Sponsor: JAZZ PHARMS

APPLICATION
NDA022033
TYPE
NDA
ORIGINAL APPROVAL
2008-02-28
LATEST ACTION
2017-01-04
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

LUVOX CR · ReferenceDiscontinued
FLUVOXAMINE MALEATE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
LUVOX CR · ReferenceDiscontinued
FLUVOXAMINE MALEATE 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2017-01-04Labeling · Supplement 11 · 901 required — Label ↗AP
2014-07-18Labeling · Supplement 10 · 901 required — Label ↗AP
2012-11-30Labeling · Supplement 9 · standard — Label ↗AP
2011-05-09Labeling · Supplement 7 · standard — Letter ↗AP
2011-05-09Labeling · Supplement 3 · standard — Label ↗AP
2011-05-09Labeling · Supplement 6 · standard — Label ↗AP
2009-02-24Labeling · Supplement 2 · standard — Label ↗AP
2008-02-28Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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