orlistat Oral Capsule

Brand(s)
Alli, Xenical
Category(s)
otc, prescription
SPL Type(s)
Human OTC, Human Prescription
Master SPL
Genentech, Inc. (2015-08-17)
Oldest Current Product
2007-02-07
License(s)
NDA
RxNORM
ORAL CAPSULE\ORLISTAT
FDAOB
ORAL\CAPSULE\ORLISTAT
SPL Active
ORAL\CAPSULE\ORLISTAT
SPL Moiety
ORAL\CAPSULE\ORLISTAT

product(s) by strength(s)

orlistat 120 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000040257XenicalNDAGenentech, Inc.2010-12-17ORLISTATORALCAPSULENDA0207665bbdc95b-82a1-4ba5-8185-6504ff68cc06

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1545694742XenicalNDAA-S Medication Solutions Llc2010-12-17ORLISTATORALCAPSULE000040257NDA020766a9c47f08-bd02-4731-aaf7-42173155b2d0

orlistat 60 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001350461AlliNDAGlaxosmithkline Consumer Healthcare Lp2007-02-07ORLISTATORALCAPSULENDA021887a2d3bd73-f3af-4ea5-a57c-66b0004cfe4f

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA020766XENICALHOFFMANN LA ROCHE INC1999-04-23p6004996NDA020766_001
2NDA021887ALLIGLAXOSMITHKLINE CONSUMER HEALTHCARE2007-02-07p6004996, SUBSTANCENDA021887_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA020766_001RXORLISTAT (120MG)ORALCAPSULETrue1999-04-23XENICAL
2NDA021887_001OTCORLISTAT (60MG)ORALCAPSULETrue2007-02-07ALLI

patent(s)

#idexpiration dateapplication(s)
1p6004996 (view patent)2018-01-06NDA020766, NDA021887

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
15bbdc95b-82a1-4ba5-8185-6504ff68cc06 (view SPL)These highlights do not include all the information needed to use XENICAL safely and effectively. See full prescribing information for XENICAL XENICAL (orlistat) Capsules for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionGenentech, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2015-08-1715000040257
2a2d3bd73-f3af-4ea5-a57c-66b0004cfe4f (view SPL)Drug FactsotcHuman OTCGlaxosmithkline Consumer Healthcare Lp2015-08-076001350461
3a9c47f08-bd02-4731-aaf7-42173155b2d0 (view SPL)These highlights do not include all the information needed to use XENICAL safely and effectively. See full prescribing information for XENICAL XENICAL (orlistat) Capsules for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel, repack2014-06-131545694742

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII