FDA NDA · NDA020766
XENICAL
orlistat
Sponsor: CHEPLAPHARM
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APPLICATION
NDA020766
TYPE
NDA
ORIGINAL APPROVAL
1999-04-23
LATEST ACTION
2026-09-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
XENICAL · ReferencePrescription
ORLISTAT 120MG · CAPSULE · ORAL
Approval history
2014-04-30Manufacturing (CMC) · Supplement 34 · priorityAP
2013-04-05Manufacturing (CMC) · Supplement 31 · priorityAP
2013-04-02Manufacturing (CMC) · Supplement 32 · priorityAP
2002-02-27Manufacturing (CMC) · Supplement 14 · priorityAP
2002-02-21Manufacturing (CMC) · Supplement 12 · priorityAP
2001-12-19Manufacturing (CMC) · Supplement 10 · priorityAP
2001-12-19Manufacturing (CMC) · Supplement 11 · priorityAP
2001-01-29Manufacturing (CMC) · Supplement 6 · priorityAP
2001-01-09Manufacturing (CMC) · Supplement 5 · priorityAP
2000-04-06Labeling · Supplement 3 · standardAP
2000-04-06Labeling · Supplement 4 · standardAP
1999-08-31Labeling · Supplement 1 · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →