Cysteamine Delayed Release Oral Capsule

Brand(s)
Procysbi
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Raptor Therapeutics Inc. (2015-08-25)
Oldest Current Product
2013-04-30
License(s)
NDA
RxNORM
DELAYED RELEASE ORAL CAPSULE\CYSTEAMINE
FDAOB
ORAL\CAPSULE, DELAYED RELEASE\CYSTEAMINE BITARTRATE
SPL Active
ORAL\CAPSULE, DELAYED RELEASE PELLETS\CYSTEAMINE BITARTRATE
SPL Moiety
ORAL\CAPSULE, DELAYED RELEASE PELLETS\CYSTEAMINE

product(s) by strength(s)

cysteamine 25 mg delayed release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1496630001ProcysbiNDARaptor Therapeutics Inc.2013-04-30CYSTEAMINE BITARTRATEORALCAPSULE, DELAYED RELEASE PELLETSNDA203389b7b6e290-5168-46dc-9e7f-5995420ec1c1

cysteamine 75 mg delayed release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1496630002ProcysbiNDARaptor Therapeutics Inc.2013-04-30CYSTEAMINE BITARTRATEORALCAPSULE, DELAYED RELEASE PELLETSNDA203389b7b6e290-5168-46dc-9e7f-5995420ec1c1

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203389PROCYSBIRAPTOR PHARMACEUTICALS INC2013-04-30p8026284, MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
p9173851, SUBSTANCE
NEW DOSAGE FORM [2016-04-30]
ORPHAN DRUG EXCLUSIVITY [2020-04-30]
NEW PATIENT POPULATION [2018-08-14]
NDA203389_001, NDA203389_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203389_001RXCYSTEAMINE BITARTRATE (EQ 25MG BASE)ORALCAPSULE, DELAYED RELEASEFalse2013-04-30PROCYSBI
2NDA203389_002RXCYSTEAMINE BITARTRATE (EQ 75MG BASE)ORALCAPSULE, DELAYED RELEASETrue2013-04-30PROCYSBI

patent(s)

#idexpiration dateapplication(s)
1p8026284 (view patent)2027-09-22NDA203389
2p9173851 (view patent)2034-06-17NDA203389

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1b7b6e290-5168-46dc-9e7f-5995420ec1c1 (view SPL)These highlights do not include all the information needed to use PROCYSBI safely and effectively. See Full Prescribing Information for PROCYSBI. PROCYSBI (cysteamine bitartrate) delayed-release capsules, for oral use Initial U.S. Approval: 1994prescriptionHuman PrescriptionRaptor Therapeutics Inc.2015-08-254496630001, 496630002

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