← FDA DRUG APPROVALS

FDA NDA · NDA021875

NUVIGIL

armodafinil

Sponsor: NUVO PHARMS

APPLICATION
NDA021875
TYPE
NDA
ORIGINAL APPROVAL
2007-06-15
LATEST ACTION
2017-02-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

NUVIGIL · ReferencePrescription
ARMODAFINIL 150MG · TABLET · ORAL
NUVIGIL · ReferencePrescription
ARMODAFINIL 50MG · TABLET · ORAL
NUVIGIL · ReferencePrescription
ARMODAFINIL 250MG · TABLET · ORAL
NUVIGIL · ReferenceDiscontinued
ARMODAFINIL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
NUVIGIL · ReferencePrescription
ARMODAFINIL 200MG · TABLET · ORAL

Approval history

2017-02-07Labeling · Supplement 23 · standard — Label ↗AP
2015-04-16Labeling · Supplement 21 · standard — Letter ↗AP
2015-02-09Manufacturing (CMC) · Supplement 20 · standardAP
2013-08-23Manufacturing (CMC) · Supplement 19 · standardAP
2013-06-28Labeling · Supplement 12 · unknown — Letter ↗AP
2013-04-05Manufacturing (CMC) · Supplement 18 · standardAP
2012-01-13REMS · Supplement 17 — Letter ↗AP
2012-01-13Labeling · Supplement 16 · standard — Letter ↗AP
2010-10-21Labeling · Supplement 15 · unknown — Label ↗AP
2010-10-21Labeling · Supplement 8 · standard — Label ↗AP
2010-10-21Labeling · Supplement 5 · standard — Label ↗AP
2009-03-26Manufacturing (CMC) · Supplement 6 — Letter ↗AP
2007-06-15Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗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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