Sapropterin Powder for Oral Solution

Brand(s)
Kuvan
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Biomarin Pharmaceutical Inc. (2015-07-08)
Oldest Current Product
2014-02-21
License(s)
NDA
RxNORM
POWDER FOR ORAL SOLUTION\SAPROPTERIN
FDAOB
ORAL\POWDER\SAPROPTERIN DIHYDROCHLORIDE
SPL Active
ORAL\POWDER, FOR SOLUTION\SAPROPTERIN DIHYDROCHLORIDE
SPL Moiety
ORAL\POWDER, FOR SOLUTION\SAPROPTERIN

product(s) by strength(s)

sapropterin dihydrochloride 100 mg powder for oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1681350301KuvanNDABiomarin Pharmaceutical Inc.2014-02-21SAPROPTERIN DIHYDROCHLORIDEORALPOWDER, FOR SOLUTIONNDA205065af38711e-8873-4790-a92d-4d583e23fb89

sapropterin dihydrochloride 500 mg powder for oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1681350482KuvanNDABiomarin Pharmaceutical Inc.2015-05-27SAPROPTERIN DIHYDROCHLORIDEORALPOWDER, FOR SOLUTIONNDA205065af38711e-8873-4790-a92d-4d583e23fb89

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA205065KUVANBIOMARIN PHARMACEUTICAL INC2013-12-19p7566714, METHOD OF USE FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA
p8067416, METHOD OF USE FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA
p7612073, TO REDUCE BLOOD PHENYLALANINE LEVELS IN PATIENTS WITH HYPERPHENYLALANINEMIA DUE TO TETRA HYDROBIOPTERIN RESPONSIVE PHENYLKETONURIA. KUVAN SHOULD BE TAKEN ORALLY WITH FOOD TO INCREASE ABSORPTION
pRE43797, KUVAN IS INDICATED TO REDUCE BLOOD PHENYLALANINE LEVELS IN PATIENTS WITH HYPERPHENYLALANINEMIA
NDA205065_001, NDA205065_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205065_001RXSAPROPTERIN DIHYDROCHLORIDE (100MG/PACKET)ORALPOWDERTrue2013-12-19KUVAN
2NDA205065_002RXSAPROPTERIN DIHYDROCHLORIDE (500MG/PACKET)ORALPOWDERFalse2015-10-27KUVAN

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p7566714 (view patent)2024-11-17NDA205065, NDA022181Sapropterin Oral Tablet
2p7612073 (view patent)2024-11-17NDA205065, NDA022181Sapropterin Oral Tablet
3p8067416 (view patent)2024-11-17NDA205065, NDA022181Sapropterin Oral Tablet
4pRE43797 (view patent)2024-11-17NDA205065, NDA022181Sapropterin Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1af38711e-8873-4790-a92d-4d583e23fb89 (view SPL)These highlights do not include all the information needed to use KUVAN safely and effectively. See full prescribing information for KUVAN. KUVAN (sapropterin dihydrochloride) tablets, for oral useKUVAN (sapropterin dihydrochloride) powder, for oral solutionInitial U.S. Approval: 2007prescriptionHuman PrescriptionBiomarin Pharmaceutical Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-07-0835681350301, 681350482, 681350300Sapropterin Oral Tablet

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