Epirubicin Injectable Solution

Brand(s)
Ellence
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmacia And Upjohn Company (2014-12-23)
Oldest Current Product
1999-09-15
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
INJECTABLE SOLUTION\EPIRUBICIN
FDAOB
INJECTION\INJECTION\EPIRUBICIN HYDROCHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\EPIRUBICIN HYDROCHLORIDE
INTRAVENOUS\INJECTION\EPIRUBICIN HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\EPIRUBICIN
INTRAVENOUS\INJECTION\EPIRUBICIN

product(s) by strength(s)

epirubicin hydrochloride 2 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000095091EllenceNDAPharmacia And Upjohn Company1999-09-15EPIRUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA0507780a03c798-a652-4895-b29c-3b521a89ba42

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007033067ANDATeva Parenteral Medicines, Inc2007-08-09EPIRUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA065331f91fc962-7c70-46a9-81fe-b98e93a2028a
2007033069ANDATeva Parenteral Medicines, Inc2007-08-09EPIRUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA065331f91fc962-7c70-46a9-81fe-b98e93a2028a
3250210203ANDASagent Pharmaceuticals2014-08-31EPIRUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA065361f9a93841-f097-472a-b4a5-ee7a2aa74164
4459630608ANDAActavis Inc.2015-01-05EPIRUBICIN HYDROCHLORIDEINTRAVENOUSINJECTIONANDA065445d42a4313-63b8-47d5-a346-817998b5bf95
5531500247ANDAAmneal-Agila, Llc2013-07-31EPIRUBICIN HYDROCHLORIDEINTRAVENOUSINJECTIONANDA091599062a2a13-d9b6-4b35-9d8d-febdd2f6cac3
6531500250ANDAAmneal-Agila, Llc2013-07-31EPIRUBICIN HYDROCHLORIDEINTRAVENOUSINJECTIONANDA091599062a2a13-d9b6-4b35-9d8d-febdd2f6cac3
7597625091NDA AUTHORIZED GENERICGreenstone Llc1999-09-15EPIRUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA050778bc0a3a39-4ac3-47de-a388-9c3672e3e130
8597625093NDA AUTHORIZED GENERICGreenstone Llc1999-09-15EPIRUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA050778bc0a3a39-4ac3-47de-a388-9c3672e3e130
9599230701ANDAAreva Pharmaceuticals,Inc.2012-07-16EPIRUBICIN HYDROCHLORIDEINTRAVENOUSINJECTIONANDA065361ab115cc4-43cd-4a59-aa01-89e356ce3a08
10617030359ANDAHospira Worldwide, Inc.2007-04-19EPIRUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA065343573eefd9-3f28-4053-a8ed-1fb531c38e15
11674570357ANDAMylan Institutional Llc2013-07-31EPIRUBICIN HYDROCHLORIDEINTRAVENOUSINJECTIONANDA0915993b59118b-7645-46b1-b3ed-3e72b2bf270c

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1667580042ANDASandoz Inc2009-12-22EPIRUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA065339140e953d-d180-4097-80da-b3ecb50465d5

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA065289EPIRUBICIN HYDROCHLORIDEEUROHEALTH INTERNATIONAL SARL2007-06-27ANDA065289_001, ANDA065289_002
2ANDA065331EPIRUBICIN HYDROCHLORIDETEVA PHARMACEUTICALS USA2007-08-09ANDA065331_001, ANDA065331_002
3ANDA065339EPIRUBICIN HYDROCHLORIDETrueEBEWE PHARMA GES MBH NFG KG2009-12-22ANDA065339_001, ANDA065339_002
4ANDA065343EPIRUBICIN HYDROCHLORIDEHOSPIRA INC2007-04-19ANDA065343_001, ANDA065343_002, ANDA065343_003, ANDA065343_004
5ANDA065361EPIRUBICIN HYDROCHLORIDECIPLA LTD2007-10-22ANDA065361_001, ANDA065361_002
6ANDA065371EPIRUBICIN HYDROCHLORIDETrueMYLAN INSTITUTIONAL LLC2007-11-28ANDA065371_001, ANDA065371_002
7ANDA065408EPIRUBICIN HYDROCHLORIDEFRESENIUS KABI USA LLC2007-10-15ANDA065408_001, ANDA065408_002, ANDA065408_003, ANDA065408_004
8ANDA065411EPIRUBICIN HYDROCHLORIDEFRESENIUS KABI ONCOLOGY PLC2007-08-20ANDA065411_001, ANDA065411_002
9ANDA065445EPIRUBICIN HYDROCHLORIDEACTAVIS TOTOWA LLC2008-09-18ANDA065445_001, ANDA065445_002, ANDA065445_003
10ANDA090075EPIRUBICIN HYDROCHLORIDEHISUN PHARMACEUTICAL (HANGZHOU) CO LTD2010-03-25ANDA090075_001, ANDA090075_002
11ANDA090163EPIRUBICIN HYDROCHLORIDEAKORN INC2009-06-24ANDA090163_001
12ANDA090266EPIRUBICIN HYDROCHLORIDETrueMUSTAFA NEVSAT ILAC SANAYII AS2011-04-15ANDA090266_001, ANDA090266_002
13ANDA091599EPIRUBICIN HYDROCHLORIDEMYLAN LABORATORIES LTD2012-03-12ANDA091599_001, ANDA091599_002
14NDA050778ELLENCEPFIZER INC1999-09-15NDA050778_001, NDA050778_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA065289_001RXEPIRUBICIN HYDROCHLORIDE (50MG/25ML)INJECTIONFalseAP2007-06-27EPIRUBICIN HYDROCHLORIDE
2ANDA065289_002RXEPIRUBICIN HYDROCHLORIDE (200MG/100ML)INJECTIONFalseAP2007-06-27EPIRUBICIN HYDROCHLORIDE
3ANDA065331_001RXEPIRUBICIN HYDROCHLORIDE (50MG/25ML)INJECTIONFalseAP2007-08-09EPIRUBICIN HYDROCHLORIDE
4ANDA065331_002RXEPIRUBICIN HYDROCHLORIDE (200MG/100ML)INJECTIONFalseAP2007-08-09EPIRUBICIN HYDROCHLORIDE
5ANDA065339_001discontinuedEPIRUBICIN HYDROCHLORIDE (50MG/25ML)INJECTIONFalse2009-12-22EPIRUBICIN HYDROCHLORIDE
6ANDA065339_002discontinuedEPIRUBICIN HYDROCHLORIDE (200MG/100ML)INJECTIONFalse2009-12-22EPIRUBICIN HYDROCHLORIDE
7ANDA065343_001RXEPIRUBICIN HYDROCHLORIDE (10MG/5ML)INJECTIONFalseAP2007-04-19EPIRUBICIN HYDROCHLORIDE
8ANDA065343_002discontinuedEPIRUBICIN HYDROCHLORIDE (50MG/25ML)INJECTIONFalse2007-04-19EPIRUBICIN HYDROCHLORIDE
9ANDA065343_003RXEPIRUBICIN HYDROCHLORIDE (150MG/75ML)INJECTIONFalseAP2007-04-19EPIRUBICIN HYDROCHLORIDE
10ANDA065343_004RXEPIRUBICIN HYDROCHLORIDE (200MG/100ML)INJECTIONFalseAP2007-04-19EPIRUBICIN HYDROCHLORIDE
11ANDA065361_001RXEPIRUBICIN HYDROCHLORIDE (50MG/25ML)INJECTIONFalseAP2007-10-22EPIRUBICIN HYDROCHLORIDE
12ANDA065361_002RXEPIRUBICIN HYDROCHLORIDE (200MG/100ML)INJECTIONFalseAP2007-10-22EPIRUBICIN HYDROCHLORIDE
13ANDA065371_001discontinuedEPIRUBICIN HYDROCHLORIDE (50MG/25ML)INJECTIONFalse2007-11-28EPIRUBICIN HYDROCHLORIDE
14ANDA065371_002discontinuedEPIRUBICIN HYDROCHLORIDE (200MG/100ML)INJECTIONFalse2007-11-28EPIRUBICIN HYDROCHLORIDE
15ANDA065408_001RXEPIRUBICIN HYDROCHLORIDE (10MG/5ML)INJECTIONFalseAP2007-10-15EPIRUBICIN HYDROCHLORIDE
16ANDA065408_002RXEPIRUBICIN HYDROCHLORIDE (50MG/25ML)INJECTIONFalseAP2007-10-15EPIRUBICIN HYDROCHLORIDE
17ANDA065408_003RXEPIRUBICIN HYDROCHLORIDE (150MG/75ML)INJECTIONFalseAP2007-10-15EPIRUBICIN HYDROCHLORIDE
18ANDA065408_004RXEPIRUBICIN HYDROCHLORIDE (200MG/100ML)INJECTIONFalseAP2007-10-15EPIRUBICIN HYDROCHLORIDE
19ANDA065411_001RXEPIRUBICIN HYDROCHLORIDE (200MG/100ML)INJECTIONFalseAP2007-08-20EPIRUBICIN HYDROCHLORIDE
20ANDA065411_002RXEPIRUBICIN HYDROCHLORIDE (50MG/25ML)INJECTIONFalseAP2007-08-20EPIRUBICIN HYDROCHLORIDE
21ANDA065445_001RXEPIRUBICIN HYDROCHLORIDE (10MG/5ML)INJECTIONFalseAP2008-09-18EPIRUBICIN HYDROCHLORIDE
22ANDA065445_002RXEPIRUBICIN HYDROCHLORIDE (50MG/25ML)INJECTIONFalseAP2008-09-18EPIRUBICIN HYDROCHLORIDE
23ANDA065445_003RXEPIRUBICIN HYDROCHLORIDE (200MG/100ML)INJECTIONFalseAP2008-09-18EPIRUBICIN HYDROCHLORIDE
24ANDA090075_001RXEPIRUBICIN HYDROCHLORIDE (50MG/25ML)INJECTIONFalseAP2010-03-25EPIRUBICIN HYDROCHLORIDE
25ANDA090075_002RXEPIRUBICIN HYDROCHLORIDE (200MG/100ML)INJECTIONFalseAP2010-03-25EPIRUBICIN HYDROCHLORIDE
26ANDA090163_001RXEPIRUBICIN HYDROCHLORIDE (50MG/25ML)INJECTIONFalseAP2009-06-24EPIRUBICIN HYDROCHLORIDE
27ANDA090266_001discontinuedEPIRUBICIN HYDROCHLORIDE (50MG/25ML)INJECTIONFalse2011-04-15EPIRUBICIN HYDROCHLORIDE
28ANDA090266_002discontinuedEPIRUBICIN HYDROCHLORIDE (200MG/100ML)INJECTIONFalse2011-04-15EPIRUBICIN HYDROCHLORIDE
29ANDA091599_001RXEPIRUBICIN HYDROCHLORIDE (50MG/25ML)INJECTIONFalseAP2012-03-12EPIRUBICIN HYDROCHLORIDE
30ANDA091599_002RXEPIRUBICIN HYDROCHLORIDE (200MG/100ML)INJECTIONFalseAP2012-03-12EPIRUBICIN HYDROCHLORIDE
31NDA050778_001RXEPIRUBICIN HYDROCHLORIDE (200MG/100ML)INJECTIONTrueAP1999-09-15ELLENCE
32NDA050778_002RXEPIRUBICIN HYDROCHLORIDE (50MG/25ML)INJECTIONFalseAP1999-09-15ELLENCE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1062a2a13-d9b6-4b35-9d8d-febdd2f6cac3 (view SPL)These highlights do not include all the information needed to useEpirubicin Hydrochloride Injectionsafely and effectively. See full prescribing information for Epirubicin Hydrochloride Injection. Epirubicin Hydrochloride InjectionforIntravenous Use Initial U.S. Approval: 1999prescriptionHuman PrescriptionAmneal-Agila, LlcANALYSIS, MANUFACTURE, PACK, STERILIZE2013-06-254531500247, 531500250
20a03c798-a652-4895-b29c-3b521a89ba42 (view SPL)These highlights do not include all the information needed to use ELLENCE safely and effectively. See full prescribing information for ELLENCE. ELLENCE (epirubicin hydrochloride injection)Initial U.S. Approval: 1999prescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-12-2311000095091, 000095093
3140e953d-d180-4097-80da-b3ecb50465d5 (view SPL)These highlights do not include all the information needed to use epirubicin hydrochloride injection safely and effectively. See full prescribing information for epirubicin hydrochloride injection. EPIRUBICIN Hydrochloride Injection for intravenous useInitial U.S. Approval: 1999prescriptionHuman PrescriptionSandoz Inc2013-11-1412667580042
43b59118b-7645-46b1-b3ed-3e72b2bf270c (view SPL)These highlights do not include all the information needed to use Epirubicin Hydrochloride Injection safely and effectively. See full prescribing information for Epirubicin Hydrochloride Injection.EPIRUBICIN hydrochloride injection, for intravenous useInitial U.S. Approval: 1999prescriptionHuman PrescriptionMylan Institutional LlcAnalysis, Label, Manufacture, Pack, Sterilize2014-03-211674570357
5573eefd9-3f28-4053-a8ed-1fb531c38e15 (view SPL)These highlights do not include all the information needed to use Epirubicin Hydrochloride Injection safely and effectively. See full prescribing information for Epirubicin Hydrochloride Injection.Epirubicin Hydrochloride Injection Initial U.S. Approval: 2007prescriptionHuman PrescriptionHospira Worldwide, Inc.2015-02-1013617030359
6ab115cc4-43cd-4a59-aa01-89e356ce3a08 (view SPL)These highlights do not include all the information needed to use EPIRUBICIN HYDROCHLORIDE safely and effectively. See full prescribing information for EPIRUBICIN HYDROCHLORIDE. EPIRUBICIN (Epirubicin hydrochloride injection) Initial U.S. Approval: 1999prescriptionHuman PrescriptionAreva Pharmaceuticals,Inc.Manufacture2012-07-041599230701
7bc0a3a39-4ac3-47de-a388-9c3672e3e130 (view SPL)These highlights do not include all the information needed to use Epirubicin HCl safely and effectively. See full prescribing information for Epirubicin HCl.Epirubicin HCl (epirubicin hydrochloride injection)Initial U.S. Approval: 1999prescriptionHuman PrescriptionGreenstone LlcMANUFACTURE2011-11-154597625091, 597625093
8d42a4313-63b8-47d5-a346-817998b5bf95 (view SPL)These highlights do not include all the information needed to use epirubicin hydrochloride injection safely and effectively. See full prescribing information for epirubicin hydrochloride injection. EPIRUBICIN hydrochloride injection, for intravenous use Initial U.S. Approval: 1999prescriptionHuman PrescriptionActavis Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-06-013459630608
9f91fc962-7c70-46a9-81fe-b98e93a2028a (view SPL)These highlights do not include all the information needed to use epirubicin hydrochloride injection safely and effectively. See full prescribing information for epirubicin hydrochloride injection. EPIRUBICIN hydrochloride injection, for intravenous useInitial U.S. Approval: 1999prescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2015-03-027007033067, 007033069
10f9a93841-f097-472a-b4a5-ee7a2aa74164 (view SPL)These highlights do not include all the information needed to use EPIRUBICIN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for EPIRUBICIN HYDROCHLORIDE INJECTION. Epirubicin Hydrochloride Injection Initial U.S. Approval: 1999prescriptionHuman PrescriptionSagent Pharmaceuticals2015-02-1712250210203

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