Paclitaxel Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira Worldwide, Inc. (2014-01-27)
Oldest Current Product
2002-05-08
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\PACLITAXEL
FDAOB
INJECTION\INJECTION\PACLITAXEL\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\PACLITAXEL
INTRAVENOUS\INJECTION, SOLUTION\PACLITAXEL
INTRAVENOUS\INJECTION\PACLITAXEL
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\PACLITAXEL
INTRAVENOUS\INJECTION, SOLUTION\PACLITAXEL
INTRAVENOUS\INJECTION\PACLITAXEL

product(s) by strength(s)

paclitaxel 6 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1445670505NDAWg Critical Care, Llc2013-07-11PACLITAXELINTRAVENOUSINJECTIONNDA0202624dbbb7c8-a4b5-484d-a2a4-4d925010fc44
2445670506NDAWg Critical Care, Llc2013-07-11PACLITAXELINTRAVENOUSINJECTIONNDA0202624dbbb7c8-a4b5-484d-a2a4-4d925010fc44

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690076ANDAPfizer Labs2011-09-30PACLITAXELINTRAVENOUSINJECTIONANDA0915401e1a3a8d-6a6b-46fd-90ae-c7ad9e9b364b
2007034764ANDATeva Parenteral Medicines, Inc2009-11-03PACLITAXELINTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA07518488d7cdd2-e650-4a16-adec-873927e03e93
3007034766ANDATeva Parenteral Medicines, Inc2008-09-24PACLITAXELINTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA07518488d7cdd2-e650-4a16-adec-873927e03e93
4007034767ANDATeva Parenteral Medicines, Inc2008-10-23PACLITAXELINTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA07518488d7cdd2-e650-4a16-adec-873927e03e93
5007034768ANDATeva Parenteral Medicines, Inc2009-09-16PACLITAXELINTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA07518488d7cdd2-e650-4a16-adec-873927e03e93
6250210213ANDASagent Pharmaceuticals2011-09-27PACLITAXELINTRAVENOUSINJECTION, SOLUTIONANDA090130973efa93-7f9d-440a-a09f-521cf331b5e7
7459630613ANDAActavis Inc.2015-01-05PACLITAXELINTRAVENOUSINJECTION, SOLUTIONANDA0901306cefbdb9-1141-4a53-9d05-f6fcc2746834
8473510009ANDAOnco Therapies Limited2011-09-30PACLITAXELINTRAVENOUSINJECTIONANDA091540566a00ae-47c0-4cd2-b602-79909bdfd9b1
9617030342ANDAHospira Worldwide, Inc.2002-05-08PACLITAXELINTRAVENOUSINJECTION, SOLUTIONANDA076131ea28753a-8631-460a-bfdc-b101eb8ac84a
10633230763ANDAApp Pharmaceuticals, Llc2009-03-20, 2014-08-15PACLITAXELINTRAVENOUSINJECTION, SOLUTIONANDA077574, ANDA090130a6c24189-293f-42ca-b969-75870bb55af0, f10f730f-6479-4f6a-8edc-fa4bd2140c1b
11667580043ANDASandoz Inc2008-01-02PACLITAXELINTRAVENOUSINJECTION, SOLUTIONANDA0781673d499be2-fdb5-4b9d-a7ce-3662ec9b2e34
12674570471ANDAMylan Institutional Llc2011-09-30PACLITAXELINTRAVENOUSINJECTIONANDA0915409ffd3e34-537f-4f65-b00e-57c25bab3b01

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075184PACLITAXELTEVA PHARMACEUTICALS USA2002-01-25ANDA075184_001
2ANDA075190PACLITAXELEUROHEALTH INTERNATIONAL SARL2002-01-28ANDA075190_001
3ANDA075278PACLITAXELTrueMYLAN PHARMACEUTICALS INC2002-01-25ANDA075278_001
4ANDA075297PACLITAXELTrueTEVA PHARMACEUTICALS USA2002-01-25ANDA075297_001
5ANDA075436PACLITAXELTrueACCORD HEALTHCARE INC2004-11-12ANDA075436_001
6ANDA076131PACLITAXELHOSPIRA INC2002-05-08ANDA076131_001
7ANDA076233PACLITAXELTrueHOSPIRA INC2002-08-01ANDA076233_001
8ANDA077413PACLITAXELTruePLIVA LACHEMA AS2008-03-12ANDA077413_001
9ANDA077574PACLITAXELFRESENIUS KABI ONCOLOGY PLC2006-11-27ANDA077574_001
10ANDA078167PACLITAXELEBEWE PHARMA GES MBH NFG KG2007-12-26ANDA078167_001
11ANDA090130PACLITAXELACTAVIS TOTOWA LLC2009-12-09ANDA090130_001
12ANDA091540PACLITAXELMYLAN LABORATORIES LTD2011-09-29ANDA091540_001
13NDA020262TAXOLHQ SPECIALTY PHARMA CORP1992-12-29NDA020262_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA075184_001RXPACLITAXEL (6MG/ML)INJECTIONFalseAP2002-01-25PACLITAXEL
2ANDA075190_001RXPACLITAXEL (6MG/ML)INJECTIONFalseAP2002-01-28PACLITAXEL
3ANDA075278_001discontinuedPACLITAXEL (6MG/ML)INJECTIONFalse2002-01-25PACLITAXEL
4ANDA075297_001discontinuedPACLITAXEL (6MG/ML)INJECTIONFalse2002-01-25PACLITAXEL
5ANDA075436_001discontinuedPACLITAXEL (6MG/ML)INJECTIONFalse2004-11-12PACLITAXEL
6ANDA076131_001RXPACLITAXEL (6MG/ML)INJECTIONTrueAP2002-05-08PACLITAXEL
7ANDA076233_001discontinuedPACLITAXEL (6MG/ML)INJECTIONFalse2002-08-01PACLITAXEL
8ANDA077413_001discontinuedPACLITAXEL (6MG/ML)INJECTIONFalse2008-03-12PACLITAXEL
9ANDA077574_001RXPACLITAXEL (6MG/ML)INJECTIONFalseAP2006-11-27PACLITAXEL
10ANDA078167_001RXPACLITAXEL (6MG/ML)INJECTIONFalseAP2007-12-26PACLITAXEL
11ANDA090130_001RXPACLITAXEL (6MG/ML)INJECTIONFalseAP2009-12-09PACLITAXEL
12ANDA091540_001RXPACLITAXEL (6MG/ML)INJECTIONFalseAP2011-09-29PACLITAXEL
13NDA020262_001RXPACLITAXEL (6MG/ML)INJECTIONFalseAP1992-12-29TAXOL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11e1a3a8d-6a6b-46fd-90ae-c7ad9e9b364b (view SPL)Paclitaxel Injection USPprescriptionHuman PrescriptionPfizer LabsAnalysis, Manufacture2011-12-071000690076
23d499be2-fdb5-4b9d-a7ce-3662ec9b2e34 (view SPL)PACLITAXEL INJECTION, USPprescriptionHuman PrescriptionSandoz Inc2015-03-209667580043
34dbbb7c8-a4b5-484d-a2a4-4d925010fc44 (view SPL)Paclitaxel Injection, USPprescriptionHuman PrescriptionWg Critical Care, Llc2015-04-092445670505, 445670506, 445670504
4566a00ae-47c0-4cd2-b602-79909bdfd9b1 (view SPL)Paclitaxel Injection USPprescriptionHuman PrescriptionOnco Therapies LimitedAnalysis, Manufacture2011-10-181473510009
56cefbdb9-1141-4a53-9d05-f6fcc2746834 (view SPL)Paclitaxel Injection USPprescriptionHuman PrescriptionActavis Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-06-176459630613
688d7cdd2-e650-4a16-adec-873927e03e93 (view SPL)Paclitaxel InjectionprescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2015-10-057007034764, 007034766, 007034767, 007034768
7973efa93-7f9d-440a-a09f-521cf331b5e7 (view SPL)PaclitaxelInjection, USP(For IV Use Only)prescriptionHuman PrescriptionSagent Pharmaceuticals2011-11-234250210213
89ffd3e34-537f-4f65-b00e-57c25bab3b01 (view SPL)Paclitaxel Injection USPprescriptionHuman PrescriptionMylan Institutional LlcAnalysis, Label, Manufacture, Pack, Sterilize2014-05-281674570471
9a6c24189-293f-42ca-b969-75870bb55af0 (view SPL)PaclitaxelRx onlyprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2011-01-216633230763
10ea28753a-8631-460a-bfdc-b101eb8ac84a (view SPL)PaclitaxelprescriptionHuman PrescriptionHospira Worldwide, Inc.2014-01-2718617030342
11f10f730f-6479-4f6a-8edc-fa4bd2140c1b (view SPL)Paclitaxel Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, Llc2014-04-304633230763

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