crofelemer Delayed Release Oral Tablet

Brand(s)
Fulyzaq
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Salix Pharmaceuticals, Inc. (2013-02-22)
Oldest Current Product
2012-12-31
License(s)
NDA
RxNORM
DELAYED RELEASE ORAL TABLET\CROFELEMER
FDAOB
ORAL\TABLET, DELAYED RELEASE\CROFELEMER
SPL Active
ORAL\TABLET, COATED\CROFELEMER
SPL Moiety
ORAL\TABLET, COATED\CROFELEMER

product(s) by strength(s)

crofelemer 125 mg delayed release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1656490802FulyzaqNDASalix Pharmaceuticals, Inc.2012-12-31CROFELEMERORALTABLET, COATEDNDA202292684ca8ce-2583-4c2d-a283-8a16fc63f8f8

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202292FULYZAQSALIX PHARMACEUTICALS INC2012-12-31p8962680, SYMPTOMATIC RELIEF OF NON-INFECTIOUS DIARRHEA
p7341744, SYMPTOMATIC RELIEF OF NON-INFECTIOUS DIARRHEA
p7323195, SUBSTANCE
p8574634, SYMPTOMATIC RELIEF OF NON-INFECTIOUS DIARRHEA
NEW CHEMICAL ENTITY [2017-12-31]NDA202292_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202292_001RXCROFELEMER (125MG)ORALTABLET, DELAYED RELEASETrue2012-12-31FULYZAQ

patent(s)

#idexpiration dateapplication(s)
1p7323195 (view patent)2018-06-07NDA202292
2p7341744 (view patent)2018-06-16NDA202292
3p8574634 (view patent)2018-01-11NDA202292
4p8962680 (view patent)2031-10-31NDA202292

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1684ca8ce-2583-4c2d-a283-8a16fc63f8f8 (view SPL)These highlights do not include all the information needed to useFULYZAQ safely and effectively. See full prescribing information forFULYZAQ. FULYZAQ (crofelemer)delayed-release tabletsfororal use Initial U.S. Approval: 2012prescriptionHuman PrescriptionSalix Pharmaceuticals, Inc.2013-02-2226656490802

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