fludarabine Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sandoz Inc (2010-05-25)
Oldest Current Product
2003-09-12
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\FLUDARABINE
FDAOB
INJECTION\INJECTION\FLUDARABINE PHOSPHATE\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\FLUDARABINE PHOSPHATE
INTRAVENOUS\INJECTION, SOLUTION\FLUDARABINE PHOSPHATE
INTRAVENOUS\INJECTION\FLUDARABINE PHOSPHATE
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\FLUDARABINE
INTRAVENOUS\INJECTION, SOLUTION\FLUDARABINE
INTRAVENOUS\INJECTION\FLUDARABINE

product(s) by strength(s)

fludarabine phosphate 25 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1667580046NDASandoz Inc2007-10-12FLUDARABINE PHOSPHATEINTRAVENOUSINJECTION, SOLUTIONNDA0221371a2d4b3a-e1f7-498e-9acc-d01f3523a1d2

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000699321ANDAPfizer Labs2011-12-22FLUDARABINE PHOSPHATEINTRAVENOUSINJECTIONANDA200647c6cda268-de1b-494d-989d-f4148d928df4
2007034852ANDATeva Parenteral Medicines, Inc2004-05-01FLUDARABINE PHOSPHATEINTRAVENOUSINJECTION, SOLUTIONANDA076661fb70b8e8-aca8-4d67-8791-063ac4081073
3007035854ANDATeva Parenteral Medicines, Inc2003-09-12FLUDARABINE PHOSPHATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA07634941470a8c-e101-4246-917e-be80cc846da3
4250210205ANDASagent Pharmaceuticals2009-02-01FLUDARABINE PHOSPHATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0786106f1094e3-4c28-40ae-a82f-37cdfa865f49
5250210237ANDASagent Pharmaceuticals2014-12-15FLUDARABINE PHOSPHATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA076349763d6c6d-cfed-4813-8cc5-41e78d357845
6459630609ANDAActavis Inc.2015-01-05FLUDARABINE PHOSPHATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0786103adca34b-4f65-4e21-8058-3c01fc7fc9bb
7617030344ANDAHospira Worldwide, Inc.2007-04-06FLUDARABINE PHOSPHATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0777904a8ae85c-66a0-48be-4099-b3c72c838176
8633230192ANDAApp Pharmaceuticals, Llc2007-11-16FLUDARABINE PHOSPHATEINTRAVENOUSINJECTION, SOLUTIONANDA078393cf5255cc-91fd-4132-973b-764dba142eae
9633230196ANDAApp Pharmaceuticals, Llc2009-12-11FLUDARABINE PHOSPHATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA078544f1ffd18c-9f6b-4479-94b9-6890bc730ecc
10674570238ANDAMylan Institutional Llc2013-01-30FLUDARABINE PHOSPHATEINTRAVENOUSINJECTION, SOLUTIONANDA090724fff47fc9-9b2f-4d57-8331-0b5fa27bb394
11674570268ANDAMylan Institutional Llc2013-01-30FLUDARABINE PHOSPHATEINTRAVENOUSINJECTION, SOLUTIONANDA090724fff47fc9-9b2f-4d57-8331-0b5fa27bb394
12674570495ANDAMylan Institutional Llc2011-12-22FLUDARABINE PHOSPHATEINTRAVENOUSINJECTIONANDA2006471cd1d006-98f1-49d6-bece-6d1674ea825c

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076349FLUDARABINE PHOSPHATETEVA PHARMACEUTICALS USA2003-08-28ANDA076349_001
2ANDA076661FLUDARABINE PHOSPHATETEVA PHARMACEUTICALS USA2004-04-28ANDA076661_001
3ANDA077790FLUDARABINE PHOSPHATEHOSPIRA WORLDWIDE, INC2007-04-06ANDA077790_001
4ANDA078393FLUDARABINE PHOSPHATEFRESENIUS KABI USA LLC2007-10-15ANDA078393_001
5ANDA078544FLUDARABINE PHOSPHATEFRESENIUS KABI USA LLC2007-10-15ANDA078544_001
6ANDA078610FLUDARABINE PHOSPHATEACTAVIS TOTOWA LLC2009-02-11ANDA078610_001
7ANDA090724FLUDARABINE PHOSPHATEMUSTAFA NEVZAT ILAC SANAYII AS (MN PHARMACEUTICALS)2010-09-27ANDA090724_001
8ANDA200647FLUDARABINE PHOSPHATEMYLAN LABORATORIES LTD2011-12-21ANDA200647_001
9ANDA200648FLUDARABINE PHOSPHATEMYLAN LABORATORIES LTD2012-10-16ANDA200648_001
10NDA020038FLUDARATrueGENZYME CORP1991-04-18NDA020038_001
11NDA022137FLUDARABINE PHOSPHATESANDOZ INC2007-09-21NDA022137_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA076349_001RXFLUDARABINE PHOSPHATE (50MG/VIAL)INJECTIONFalseAP2003-08-28FLUDARABINE PHOSPHATE
2ANDA076661_001RXFLUDARABINE PHOSPHATE (50MG/2ML)INJECTIONFalseAP2004-04-28FLUDARABINE PHOSPHATE
3ANDA077790_001RXFLUDARABINE PHOSPHATE (50MG/VIAL)INJECTIONTrueAP2007-04-06FLUDARABINE PHOSPHATE
4ANDA078393_001RXFLUDARABINE PHOSPHATE (50MG/2ML)INJECTIONTrueAP2007-10-15FLUDARABINE PHOSPHATE
5ANDA078544_001RXFLUDARABINE PHOSPHATE (50MG/VIAL)INJECTIONFalseAP2007-10-15FLUDARABINE PHOSPHATE
6ANDA078610_001RXFLUDARABINE PHOSPHATE (50MG/VIAL)INJECTIONFalseAP2009-02-11FLUDARABINE PHOSPHATE
7ANDA090724_001RXFLUDARABINE PHOSPHATE (50MG/2ML)INJECTIONFalseAP2010-09-27FLUDARABINE PHOSPHATE
8ANDA200647_001RXFLUDARABINE PHOSPHATE (50MG/2ML)INJECTIONFalseAP2011-12-21FLUDARABINE PHOSPHATE
9ANDA200648_001RXFLUDARABINE PHOSPHATE (50MG/VIAL)INJECTIONFalseAP2012-10-16FLUDARABINE PHOSPHATE
10NDA020038_001discontinuedFLUDARABINE PHOSPHATE (50MG/VIAL)INJECTIONFalse1991-04-18FLUDARA
11NDA022137_001RXFLUDARABINE PHOSPHATE (50MG/2ML)INJECTIONTrueAP2007-09-21FLUDARABINE PHOSPHATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11a2d4b3a-e1f7-498e-9acc-d01f3523a1d2 (view SPL)These highlights do not include all the information needed to use Fludarabine Phosphate Injection safely and effectively. See full prescribing information for Fludarabine Phosphate Injection.Fludarabine Phosphate InjectionInitial U.S. Approval: 1991prescriptionHuman PrescriptionSandoz Inc2010-05-2510667580046
21cd1d006-98f1-49d6-bece-6d1674ea825c (view SPL)Fludarabine Phosphate Injection, USPprescriptionHuman PrescriptionMylan Institutional LlcAnalysis, Label, Manufacture, Pack, Sterilize2014-02-121674570495
33adca34b-4f65-4e21-8058-3c01fc7fc9bb (view SPL)Fludarabine Phosphate for Injection, USPprescriptionHuman PrescriptionActavis Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-06-018459630609
441470a8c-e101-4246-917e-be80cc846da3 (view SPL)Fludarabine Phosphate for Injection USPprescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2015-01-074007035854
54a8ae85c-66a0-48be-4099-b3c72c838176 (view SPL)Fludarabine Phosphate for Injection, USPprescriptionHuman PrescriptionHospira Worldwide, Inc.2013-09-104617030344
66f1094e3-4c28-40ae-a82f-37cdfa865f49 (view SPL)Fludarabine Phosphate for Injection, USP(For IV Use Only)prescriptionHuman PrescriptionSagent Pharmaceuticals2015-04-217250210205
7763d6c6d-cfed-4813-8cc5-41e78d357845 (view SPL)Fludarabine Phosphate for Injection, USP(For Intravenous Use Only)prescriptionHuman PrescriptionSagent Pharmaceuticals2014-10-302250210237
8c6cda268-de1b-494d-989d-f4148d928df4 (view SPL)Fludarabine Phosphate Injection, USP 25mg/mLprescriptionHuman PrescriptionPfizer LabsAnalysis, Manufacture, Pack, Sterilize2012-04-162000699321
9cf5255cc-91fd-4132-973b-764dba142eae (view SPL)Fludarabine Phosphate Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2011-05-102633230192
10f1ffd18c-9f6b-4479-94b9-6890bc730ecc (view SPL)Fludarabine Phosphate for Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2009-12-111633230196
11fb70b8e8-aca8-4d67-8791-063ac4081073 (view SPL)These highlights do not include all the information needed to use Fludarabine Phosphate Injection USP safely and effectively. See full prescribing information for Fludarabine Phosphate Injection USP.FLUDARABINE PHOSPHATE InjectionFor Intravenous use onlyInitial U.S. Approval: 1991prescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2015-10-285007034852
12fff47fc9-9b2f-4d57-8331-0b5fa27bb394 (view SPL)Fludarabine Phosphate Injection, USPprescriptionHuman PrescriptionMylan Institutional Llc2012-11-303674570238, 674570268

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