← FDA DRUG APPROVALS

FDA NDA · NDA020766

XENICAL

orlistat

Sponsor: CHEPLAPHARM

APPLICATION
NDA020766
TYPE
NDA
ORIGINAL APPROVAL
1999-04-23
LATEST ACTION
2022-11-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

XENICAL · ReferencePrescription
ORLISTAT 120MG · CAPSULE · ORAL

Approval history

2022-11-17Labeling · Supplement 38 · standard — Letter ↗AP
2016-08-12Labeling · Supplement 36 · standard — Letter ↗AP
2015-08-07Labeling · Supplement 35 · standard — Letter ↗AP
2014-04-30Manufacturing (CMC) · Supplement 34 · priorityAP
2013-10-16Labeling · Supplement 33 · standard — Label ↗AP
2013-04-05Manufacturing (CMC) · Supplement 31 · priorityAP
2013-04-02Manufacturing (CMC) · Supplement 32 · priorityAP
2012-01-20Labeling · Supplement 29 · unknown — Label ↗AP
2010-12-17Manufacturing (CMC) · Supplement 30 · priority — Label ↗AP
2010-05-25Labeling · Supplement 28 · unknown — Label ↗AP
2009-02-11Labeling · Supplement 26 · standard — Label ↗AP
2007-01-05Labeling · Supplement 22 · standard — Label ↗AP
2005-09-02Labeling · Supplement 21 · standard — Review ↗AP
2004-10-22Efficacy · Supplement 19 · standard — Review ↗AP
2004-07-09Labeling · Supplement 20 · standard — Label ↗AP
2003-12-12Efficacy · Supplement 18 · priority — Pediatric Medical Review ↗AP
2002-03-08Manufacturing (CMC) · Supplement 13 · priority — Review ↗AP
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
2001-11-12Manufacturing (CMC) · Supplement 9 · priority — Review ↗AP
2001-06-25Labeling · Supplement 7 · standard — Label ↗AP
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
1999-04-23Type 1 - New Molecular Entity · Original · priority — 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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