Verteporfin Injectable Solution

Brand(s)
Visudyne
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Qlt Ophthalmics, Inc. (2010-04-07)
Oldest Current Product
2000-04-12
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\VERTEPORFIN
FDAOB
INJECTION\INJECTION\VERTEPORFIN\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\VERTEPORFIN
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\VERTEPORFIN

product(s) by strength(s)

verteporfin 2 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1502360001VisudyneNDAQlt Ophthalmics, Inc.2000-04-12VERTEPORFININTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA02111931512723-9ff0-4e18-aa3a-55ab833038c6

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA021119VISUDYNEVALEANT PHARMACEUTICALS LUXEMBOURG SARL2000-04-12p5770619, USE OF THE DRUG PRODUCT IN PHOTODYNAMIC THERAPEUTIC PROTOCOLS FOR THE TREATMENT OF AGE-RELATED MACULAR DEGENERATION AND RELATED CONDITIONS INVOLVING UNWANTED NEOVASCULATURE IN THE EYE
p5756541, USE OF THE DRUG PRODUCT IN PHOTODYNAMIC THERAPEUTIC PROTOCOLS FOR THE TREATMENT OF AGE-RELATED MACULAR DEGENERATION AND RELATED CONDITIONS INVOLVING UNWANTED NEOVASCULATURE IN THE EYE
p5707608
p5798349, USE OF THE DRUG PRODUCT IN PHOTODYNAMIC THERAPEUTIC PROTOCOLS FOR THE TREATMENT OF AGE-RELATED MACULAR DEGENERATION AND RELATED CONDITIONS INVOLVING UNWANTED NEOVASCULATURE IN THE EYE
NDA021119_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA021119_001RXVERTEPORFIN (15MG/VIAL)INJECTIONTrue2000-04-12VISUDYNE

patent(s)

#idexpiration dateapplication(s)
1p5707608 (view patent)2015-08-02NDA021119
2p5756541 (view patent)2016-03-11NDA021119
3p5770619 (view patent)2015-01-06NDA021119
4p5798349 (view patent)2015-08-25NDA021119

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
131512723-9ff0-4e18-aa3a-55ab833038c6 (view SPL)VISUDYNE (VERTEPORFIN FOR INJECTION)prescriptionHuman PrescriptionQlt Ophthalmics, Inc.2010-04-072502360001
2952f4c80-50b1-4308-9ee6-311ffefb13df (view SPL)VISUDYNE (VERTEPORFIN FOR INJECTION)prescriptionHuman PrescriptionValeant Pharmaceuticals North America LlcMANUFACTURE2014-02-274001875600

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