Epoprostenol Injectable Solution

Brand(s)
Flolan, Veletri
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Parenteral Medicines, Inc (2012-12-19)
Oldest Current Product
1995-12-08
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\EPOPROSTENOL
FDAOB
INJECTION\INJECTION\EPOPROSTENOL SODIUM\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\EPOPROSTENOL SODIUM
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\EPOPROSTENOL
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\EPOPROSTENOL SODIUM
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\EPOPROSTENOL
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\EPOPROSTENOL

product(s) by strength(s)

epoprostenol 0.1 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1662150403VeletriNDAActelion Pharmaceuticals Us, Inc.2010-04-22EPOPROSTENOLINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA022260df502787-46ec-4dd1-a2c0-be90f6d95a5d

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007031985ANDATeva Parenteral Medicines, Inc2008-04-23EPOPROSTENOL SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA07839656733651-d331-4e69-a6a3-303756ccc53c

epoprostenol 0.3 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730519FlolanNDAGlaxosmithkline Llc1995-12-08EPOPROSTENOL SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA0204448e4b636e-ee9c-4111-779d-28c8369d283b
2662150401VeletriNDAActelion Pharmaceuticals Us, Inc.2010-04-22EPOPROSTENOL SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA022260d669ff68-ddcf-42f6-913c-d8f1aedbd9c4

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007031995ANDATeva Parenteral Medicines, Inc2008-04-23EPOPROSTENOL SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA07839656733651-d331-4e69-a6a3-303756ccc53c

application(s)

#idtitleapplicantapprovedpatentapproved drugin other drug docs
1ANDA078396EPOPROSTENOL SODIUMTEVA PHARMACEUTICALS USA2008-04-23ANDA078396_001, ANDA078396_002Water Injectable Solution
2NDA020444FLOLANGLAXOSMITHKLINE LLC1995-09-20NDA020444_001, NDA020444_002Water Injectable Solution
3NDA022260VELETRIACTELION PHARMACEUTICALS LTD2008-06-27p8318802, SUBSTANCE
p8598227
NDA022260_001, NDA022260_002Water Injectable Solution

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA078396_001RXEPOPROSTENOL SODIUM (EQ 0.5MG BASE/VIAL)INJECTIONFalseAP2008-04-23EPOPROSTENOL SODIUM
2ANDA078396_002RXEPOPROSTENOL SODIUM (EQ 1.5MG BASE/VIAL)INJECTIONFalseAP2008-04-23EPOPROSTENOL SODIUM
3NDA020444_001RXEPOPROSTENOL SODIUM (EQ 0.5MG BASE/VIAL)INJECTIONTrueAP1995-09-20FLOLAN
4NDA020444_002RXEPOPROSTENOL SODIUM (EQ 1.5MG BASE/VIAL)INJECTIONTrueAP1995-09-20FLOLAN
5NDA022260_001RXEPOPROSTENOL SODIUM (EQ 1.5MG BASE/VIAL)INJECTIONTrue2008-06-27VELETRI
6NDA022260_002RXEPOPROSTENOL SODIUM (EQ 0.5MG BASE/VIAL)INJECTIONFalse2012-06-28VELETRI

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p8318802 (view patent)2027-03-15NDA022260Water Injectable Solution
2p8598227 (view patent)2027-02-02NDA022260Water Injectable Solution

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)in other drug docs
156733651-d331-4e69-a6a3-303756ccc53c (view SPL)Epoprostenol Sodium for InjectionPrescribing InformationRx onlyprescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2012-12-193007031985, 007031995, 007039258Water Injectable Solution
28e4b636e-ee9c-4111-779d-28c8369d283b (view SPL)These highlights do not include all the information needed to use FLOLAN safely and effectively. See full prescribing information for FLOLAN. FLOLAN (epoprostenol sodium) for injection, for intravenous useInitial U.S. Approval: 1995prescriptionHuman PrescriptionGlaxosmithkline Llc2015-04-2110001730519, 001730517
3d669ff68-ddcf-42f6-913c-d8f1aedbd9c4 (view SPL)These highlights do not include all the information needed to use VELETRI safely and effectively. See full prescribing information for VELETRI. VELETRI (epoprostenol) for Injection Initial U.S. Approval: 1995prescriptionHuman PrescriptionActelion Pharmaceuticals Us, Inc.2011-06-014662150401
4df502787-46ec-4dd1-a2c0-be90f6d95a5d (view SPL)These highlights do not include all the information needed to use VELETRI safely and effectively. See full prescribing information for VELETRI. VELETRI (epoprostenol) for Injection Initial U.S. Approval: 1995prescriptionHuman PrescriptionActelion Pharmaceuticals Us, Inc.2012-06-013662150403, 662150402

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