Topotecan Injectable Solution

Brand(s)
Hycamtin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2014-07-15)
Oldest Current Product
2010-11-28
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\TOPOTECAN
FDAOB
INJECTION\INJECTION\TOPOTECAN HYDROCHLORIDE\rdfq
INTRAVENOUS\SOLUTION\TOPOTECAN HYDROCHLORIDE
SPL Active
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\TOPOTECAN HYDROCHLORIDE
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\TOPOTECAN HYDROCHLORIDE
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\TOPOTECAN HYDROCHLORIDE
INTRAVENOUS\INJECTION\TOPOTECAN HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\TOPOTECAN
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\TOPOTECAN
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\TOPOTECAN
INTRAVENOUS\INJECTION\TOPOTECAN

product(s) by strength(s)

topotecan 1 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004090302NDAHospira, Inc.2011-02-02, 2013-09-24TOPOTECAN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATENDA2005821d4e1cce-c57e-4a8b-be96-f95a2778e221, cc201919-b959-46ce-b0a8-2020e08d500a
2250210236NDASagent Pharmaceuticals2014-12-15TOPOTECAN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATENDA022453e5e6600e-6f92-4dc9-a8f3-cf647471d3cb

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690075ANDAPfizer Labs2012-08-29TOPOTECAN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA09154222a58c47-f126-4701-a120-b3701d07a916
2167290151ANDAAccord Healthcare Inc.2013-07-23TOPOTECAN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA202351729b2b22-1344-44f3-b614-14f6ec3c263e
3250210206ANDASagent Pharmaceuticals2010-11-28TOPOTECAN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0912846317ed83-75e3-4392-874b-9818c15a067d
4250210824ANDASagent Pharmaceuticals2011-06-27TOPOTECAN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA090620b75e8568-e5f0-41f5-948b-fc9f807533b5
5459630615ANDAActavis Inc.2015-01-05TOPOTECAN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA090620996430c0-ee26-4ed9-82b8-a8b645becba6
6553900370ANDABedford Laboratories2011-04-18TOPOTECAN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA201191a439bf07-53db-0352-846a-99d9da772f9b
7627560023ANDASun Pharmaceutical Industries Limited2015-09-02TOPOTECAN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA202203f394ace4-e201-4055-acea-453830d103a6
8633230762ANDAApp Pharmaceuticals, Llc2010-11-29, 2010-11-30TOPOTECAN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA091089, ANDA09137679f3b5ee-fc95-47c3-96a4-55dd91121e55, b094e6ba-7cf6-4fb8-8683-73d324650dd3
9664350410ANDAKadmon Pharmaceuticals, Llc2010-12-02TOPOTECAN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA091199715620fb-614f-40b6-8d3d-8494843d8518
10674570474ANDAMylan Institutional Llc2012-08-29TOPOTECAN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0915421ca916c3-48dc-498d-8b5c-dab735c29e42

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1667580051NDASandoz Inc2011-02-25TOPOTECAN HYDROCHLORIDEINTRAVENOUSINJECTIONNDA2001996bc88223-4de9-4ff7-b59f-e479c1fce600

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA090620TOPOTECAN HYDROCHLORIDEACTAVIS TOTOWA LLC2010-12-02ANDA090620_001
2ANDA091089TOPOTECAN HYDROCHLORIDEFRESENIUS KABI USA LLC2010-11-29ANDA091089_001
3ANDA091199TOPOTECAN HYDROCHLORIDECIPLA LTD2010-12-01ANDA091199_001
4ANDA091284TOPOTECAN HYDROCHLORIDESAGENT PHARMACEUTICALS INC2011-01-26ANDA091284_001
5ANDA091376TOPOTECAN HYDROCHLORIDETrueFRESENIUS KABI ONCOLOGY PLC2010-11-29ANDA091376_001
6ANDA091542TOPOTECAN HYDROCHLORIDEMYLAN LABORATORIES LTD2012-08-28ANDA091542_001
7ANDA201166TOPOTECAN HYDROCHLORIDECHEM WERTH INC2012-08-08ANDA201166_001
8ANDA201191TOPOTECAN HYDROCHLORIDEDR REDDYS LABORATORIES LTD2011-03-09ANDA201191_001
9ANDA202203TOPOTECAN HYDROCHLORIDESUN PHARMACEUTICAL INDUSTRIES LTD2013-08-29ANDA202203_001
10ANDA202351TOPOTECAN HYDROCHLORIDEACCORD HEALTHCARE INC2013-06-26ANDA202351_001
11NDA020671HYCAMTINNOVARTIS PHARMACEUTICALS CORP1996-05-28p5674872, TREATMENT OF METASTATIC CARCINOMA OF THE OVARY AFTER FAILURE OF INITIAL OR SUBSEQUENT CHEMOTHERAPYNDA020671_001
12NDA022453TOPOTECAN HYDROCHLORIDETEVA PHARMACEUTICALS USA2012-12-20NDA022453_001
13NDA200199TOPOTECANTrueSANDOZ INC2011-02-25NDA200199_001, NDA200199_002, NDA200199_003
14NDA200582TOPOTECAN HYDROCHLORIDEHOSPIRA INC2011-02-02NDA200582_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA090620_001RXTOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/VIAL)INJECTIONFalseAP2010-12-02TOPOTECAN HYDROCHLORIDE
2ANDA091089_001RXTOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/VIAL)INJECTIONFalseAP2010-11-29TOPOTECAN HYDROCHLORIDE
3ANDA091199_001RXTOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/VIAL)INJECTIONFalseAP2010-12-01TOPOTECAN HYDROCHLORIDE
4ANDA091284_001RXTOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/VIAL)INJECTIONFalseAP2011-01-26TOPOTECAN HYDROCHLORIDE
5ANDA091376_001discontinuedTOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/VIAL)INJECTIONFalse2010-11-29TOPOTECAN HYDROCHLORIDE
6ANDA091542_001RXTOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/VIAL)INJECTIONFalseAP2012-08-28TOPOTECAN HYDROCHLORIDE
7ANDA201166_001RXTOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/VIAL)INJECTIONFalseAP2012-08-08TOPOTECAN HYDROCHLORIDE
8ANDA201191_001RXTOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/VIAL)INJECTIONFalseAP2011-03-09TOPOTECAN HYDROCHLORIDE
9ANDA202203_001RXTOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/VIAL)INJECTIONFalseAP2013-08-29TOPOTECAN HYDROCHLORIDE
10ANDA202351_001RXTOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/VIAL)INJECTIONFalseAP2013-06-26TOPOTECAN HYDROCHLORIDE
11NDA020671_001RXTOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/VIAL)INJECTIONTrueAP1996-05-28HYCAMTIN
12NDA022453_001RXTOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/4ML)INTRAVENOUSSOLUTIONFalseAP2012-12-20TOPOTECAN HYDROCHLORIDE
13NDA200199_001discontinuedTOPOTECAN HYDROCHLORIDE (EQ 1MG BASE/ML)INTRAVENOUSSOLUTIONFalse2011-02-25TOPOTECAN
14NDA200199_002discontinuedTOPOTECAN HYDROCHLORIDE (EQ 3MG BASE/3ML)INTRAVENOUSSOLUTIONFalse2011-02-25TOPOTECAN
15NDA200199_003discontinuedTOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/4ML)INTRAVENOUSSOLUTIONFalse2011-02-25TOPOTECAN
16NDA200582_001RXTOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/4ML)INTRAVENOUSSOLUTIONTrueAP2011-02-02TOPOTECAN HYDROCHLORIDE

patent(s)

#idexpiration dateapplication(s)
1p5674872 (view patent)2014-10-07NDA020671

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11ca916c3-48dc-498d-8b5c-dab735c29e42 (view SPL)These highlights do not include all the information needed to use Topotecan Hydrochloride for Injection safely and effectively. See full prescribing information for Topotecan Hydrochloride for Injection.TOPOTECAN hydrochloride for injection, for intravenous use.Initial U.S. Approval: 1996prescriptionHuman PrescriptionMylan Institutional LlcAnalysis, Label, Manufacture, Pack, Sterilize2014-07-011674570474
21d4e1cce-c57e-4a8b-be96-f95a2778e221 (view SPL)These highlights do not include all the information needed to use Topotecan Injection safely and effectively. See full prescribing information for Topotecan Injection. TOPOTECAN INJECTION Must be diluted before intravenous infusion Initial U.S. Approval: 1996prescriptionHuman PrescriptionHospira, Inc.2014-07-1516004090302
322a58c47-f126-4701-a120-b3701d07a916 (view SPL)These highlights do not include all the information needed to use Topotecan Hydrochloride for Injection safely and effectively. See full prescribing information for Topotecan Hydrochloride for Injection.Initial U.S. Approval: 1996prescriptionHuman PrescriptionPfizer LabsAnalysis, Manufacture, Pack, Sterilize2012-09-101000690075
43c15da96-d309-4b93-f5aa-cfb52c25c174 (view SPL)These highlights do not include all the information needed to use HYCAMTIN safely and effectively. See full prescribing information for HYCAMTIN.HYCAMTIN (topotecan) for injectionInitial U.S. Approval: 1996prescriptionHuman PrescriptionGlaxosmithkline Llc2015-06-0210000074201
56317ed83-75e3-4392-874b-9818c15a067d (view SPL)These highlights do not include all the information needed to use topotecan hydrochloride safely and effectively. See full prescribing information for topotecan hydrochloride. Topotecan Hydrochloride for Injection Initial U.S. Approval: 1996prescriptionHuman PrescriptionSagent Pharmaceuticals2010-11-264250210206
66bc88223-4de9-4ff7-b59f-e479c1fce600 (view SPL)These highlights do not include all the information needed to use Topotecan Injection safely and effectively. See full prescribing information for Topotecan Injection. Must be diluted before intravenous infusion Initial U.S. Approval: 1996prescriptionHuman PrescriptionSandoz Inc2011-03-091667580051
7715620fb-614f-40b6-8d3d-8494843d8518 (view SPL)These highlights do not include all the information needed to use (Topotecan Hydrochloride for Injection) safely and effectively. See full prescribing information for (Topotecan Hydrochloride for Injection). Topotecan Hydrochloride for InjectionInitial U.S. Approval: 1996prescriptionHuman PrescriptionKadmon Pharmaceuticals, LlcAPI MANUFACTURE, MANUFACTURE2010-12-101664350410
8729b2b22-1344-44f3-b614-14f6ec3c263e (view SPL)These highlights do not include all the information needed to use topotecan for injection safely and effectively. See full prescribing information for topotecan for injection. TOPOTECAN for injection Initial U.S. Approval: 1996prescriptionHuman PrescriptionAccord Healthcare Inc.analysis, manufacture2015-10-235167290151
979f3b5ee-fc95-47c3-96a4-55dd91121e55 (view SPL)These highlights do not include all the information needed to use Topotecan Hydrochloride for Injection safely and effectively. See full prescribing information for Topotecan Hydrochloride for Injection.Topotecan Hydrochloride for InjectionInitial U.S. Approval: 1996prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2010-11-255633230762
109683e3be-7d23-4ba7-9fe9-9762963604f0 (view SPL)These highlights do not include all the information needed to use TOPOTECAN INJECTION safely and effectively. See full prescribing information for TOPOTECAN INJECTION. TOPOTECAN INJECTION, for intravenous use Initial U.S. Approval: 1996prescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2014-03-074007034714
11996430c0-ee26-4ed9-82b8-a8b645becba6 (view SPL)These highlights do not include all the information needed to use TOPOTECAN HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for TOPOTECAN HYDROCHLORIDE FOR INJECTION. TOPOTECAN hydrochloride for injection, for intravenous use Initial U.S. Approval: 1996prescriptionHuman PrescriptionActavis Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-07-315459630615
12a439bf07-53db-0352-846a-99d9da772f9b (view SPL)These highlights do not include all the information needed to use (Topotecan Hydrochloride For Injection) safely and effectively. See full prescribing information for (topotecan hydrochloride for injection). Topotecan Hydrochloride For Injection Initial U.S. Approval: 1996prescriptionHuman PrescriptionBedford Laboratoriesanalysis, manufacture2014-04-113553900370
13b094e6ba-7cf6-4fb8-8683-73d324650dd3 (view SPL)These highlights do not include all the information needed to use Topotecan Hydrochloride for Injection safely and effectively. See full prescribing information for Topotecan Hydrochloride for Injection. Topotecan Hydrochloride for Injection Initial U.S. Approval: 1996prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2013-03-011633230762
14b75e8568-e5f0-41f5-948b-fc9f807533b5 (view SPL)These highlights do not include all the information needed to use Topotecan Hydrochloride for Injection safely and effectively. See full prescribing information for Topotecan Hydrochloride for Injection. Topotecan Hydrochloride for Injection Initial U.S. Approval: 1996prescriptionHuman PrescriptionSagent Pharmaceuticals2011-03-101250210824
15cc201919-b959-46ce-b0a8-2020e08d500a (view SPL)These highlights do not include all the information needed to use Topotecan Injection safely and effectively. See full prescribing information for Topotecan Injection. TOPOTECAN INJECTION Must be diluted before intravenous infusion Initial U.S. Approval: 1996prescriptionHuman PrescriptionHospira, Inc.2014-07-151004090302
16e5e6600e-6f92-4dc9-a8f3-cf647471d3cb (view SPL)These highlights do not include all the information needed to use Topotecan Injection safely and effectively. See full prescribing information for Topotecan Injection.Topotecan Injection, for intravenous useInitial U.S. Approval: 1996prescriptionHuman PrescriptionSagent Pharmaceuticals2014-09-123250210236
17f394ace4-e201-4055-acea-453830d103a6 (view SPL)These highlights do not include all the information needed to use TOPOTECAN HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for TOPOTECAN HYDROCHLORIDE FOR INJECTION TOPOTECAN hydrochloride for injection For Intravenous Infusion Initial U.S. Approval: 1996prescriptionHuman PrescriptionSun Pharmaceutical Industries LimitedANALYSIS, MANUFACTURE2015-09-025627560023

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