Idarubicin Injectable Solution

Brand(s)
Idamycin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmacia And Upjohn Company (2015-01-06)
Oldest Current Product
1997-02-17
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\IDARUBICIN
FDAOB
INJECTION\INJECTION\IDARUBICIN HYDROCHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\IDARUBICIN HYDROCHLORIDE
INTRAVENOUS\INJECTION\IDARUBICIN HYDROCHLORIDE
INTRAVENOUS\SOLUTION\IDARUBICIN HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\IDARUBICIN
INTRAVENOUS\INJECTION\IDARUBICIN
INTRAVENOUS\SOLUTION\IDARUBICIN

product(s) by strength(s)

idarubicin hydrochloride 1 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000132586IdamycinNDAPharmacia And Upjohn Company1997-02-17IDARUBICIN HYDROCHLORIDEINTRAVENOUSSOLUTIONNDA0507340a5a6d93-cc1e-4d7f-8da1-446c134503b3
2000132596IdamycinNDAPharmacia And Upjohn Company1997-02-17IDARUBICIN HYDROCHLORIDEINTRAVENOUSSOLUTIONNDA0507340a5a6d93-cc1e-4d7f-8da1-446c134503b3

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007034154ANDATeva Parenteral Medicines, Inc2002-10-01IDARUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA065036d521b65f-3fd2-4efe-8cab-b444921dd223
2007034155ANDATeva Parenteral Medicines, Inc2002-10-01IDARUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA065036d521b65f-3fd2-4efe-8cab-b444921dd223
3007034156ANDATeva Parenteral Medicines, Inc2002-10-01IDARUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA065036d521b65f-3fd2-4efe-8cab-b444921dd223
4531500336ANDAAmneal-Agila, Llc2013-04-30IDARUBICIN HYDROCHLORIDEINTRAVENOUSINJECTIONANDA20014431c9691c-aa14-426d-b67f-f8d25e7200ce
5531500386ANDAAmneal-Agila, Llc2013-04-30IDARUBICIN HYDROCHLORIDEINTRAVENOUSINJECTIONANDA20014431c9691c-aa14-426d-b67f-f8d25e7200ce
6531500411ANDAAmneal-Agila, Llc2013-04-30IDARUBICIN HYDROCHLORIDEINTRAVENOUSINJECTIONANDA20014431c9691c-aa14-426d-b67f-f8d25e7200ce
7633230194ANDAApp Pharmaceuticals, Llc2009-08-11IDARUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA065440e6b1716d-71ea-4e2b-996d-67ec40759672

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1667580055ANDASandoz Inc2011-03-29IDARUBICIN HYDROCHLORIDEINTRAVENOUSINJECTIONANDA091293615d206a-b178-4ff4-b6c1-7e349099f3c7

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA065036IDARUBICIN HYDROCHLORIDE PFSTEVA PHARMACEUTICALS USA2002-05-01ANDA065036_001
2ANDA065037IDARUBICIN HYDROCHLORIDETrueTEVA PARENTERAL MEDICINES INC2002-05-01ANDA065037_001, ANDA065037_002, ANDA065037_003
3ANDA065275IDARUBICIN HYDROCHLORIDEEUROHEALTH INTERNATIONAL SARL2006-12-14ANDA065275_001
4ANDA065288IDARUBICIN HYDROCHLORIDEEUROHEALTH INTERNATIONAL SARL2007-05-15ANDA065288_001
5ANDA065440IDARUBICIN HYDROCHLORIDEFRESENIUS KABI USA LLC2009-08-04ANDA065440_001
6ANDA091293IDARUBICIN HYDROCHLORIDETrueSANDOZ INC2011-03-29ANDA091293_001
7ANDA200144IDARUBICIN HYDROCHLORIDEMYLAN LABORATORIES LTD2012-10-11ANDA200144_001
8NDA050661IDAMYCINTruePHARMACIA AND UPJOHN CO1990-09-27NDA050661_001, NDA050661_002, NDA050661_003
9NDA050734IDAMYCIN PFSPHARMACIA AND UPJOHN CO1997-02-17NDA050734_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA065036_001RXIDARUBICIN HYDROCHLORIDE (1MG/ML)INJECTIONFalseAP2002-05-01IDARUBICIN HYDROCHLORIDE PFS
2ANDA065037_001discontinuedIDARUBICIN HYDROCHLORIDE (20MG/VIAL)INJECTIONFalse2002-05-01IDARUBICIN HYDROCHLORIDE
3ANDA065037_002discontinuedIDARUBICIN HYDROCHLORIDE (10MG/VIAL)INJECTIONFalse2002-05-01IDARUBICIN HYDROCHLORIDE
4ANDA065037_003discontinuedIDARUBICIN HYDROCHLORIDE (5MG/VIAL)INJECTIONFalse2002-05-01IDARUBICIN HYDROCHLORIDE
5ANDA065275_001RXIDARUBICIN HYDROCHLORIDE (1MG/ML)INJECTIONFalseAP2006-12-14IDARUBICIN HYDROCHLORIDE
6ANDA065288_001RXIDARUBICIN HYDROCHLORIDE (1MG/ML)INJECTIONFalseAP2007-05-15IDARUBICIN HYDROCHLORIDE
7ANDA065440_001RXIDARUBICIN HYDROCHLORIDE (1MG/ML)INJECTIONFalseAP2009-08-04IDARUBICIN HYDROCHLORIDE
8ANDA091293_001discontinuedIDARUBICIN HYDROCHLORIDE (1MG/ML)INJECTIONFalse2011-03-29IDARUBICIN HYDROCHLORIDE
9ANDA200144_001RXIDARUBICIN HYDROCHLORIDE (1MG/ML)INJECTIONFalseAP2012-10-11IDARUBICIN HYDROCHLORIDE
10NDA050661_001discontinuedIDARUBICIN HYDROCHLORIDE (10MG/VIAL)INJECTIONFalse1990-09-27IDAMYCIN
11NDA050661_002discontinuedIDARUBICIN HYDROCHLORIDE (5MG/VIAL)INJECTIONFalse1990-09-27IDAMYCIN
12NDA050661_003discontinuedIDARUBICIN HYDROCHLORIDE (20MG/VIAL)INJECTIONFalse1995-04-25IDAMYCIN
13NDA050734_001RXIDARUBICIN HYDROCHLORIDE (1MG/ML)INJECTIONTrueAP1997-02-17IDAMYCIN PFS

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10a5a6d93-cc1e-4d7f-8da1-446c134503b3 (view SPL)Idamycin PFS idarubicin hydrochloride injectionprescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-01-066000132586, 000132596, 000132576
231c9691c-aa14-426d-b67f-f8d25e7200ce (view SPL)Idarubicin Hydrochloride Injection Rx only FOR INTRAVENOUS USE ONLYprescriptionHuman PrescriptionAmneal-Agila, LlcANALYSIS, MANUFACTURE, PACK, STERILIZE2012-12-281531500336, 531500386, 531500411
3615d206a-b178-4ff4-b6c1-7e349099f3c7 (view SPL)Idarubicin Hydrochloride InjectionprescriptionHuman PrescriptionSandoz Inc2011-04-061667580055
4d521b65f-3fd2-4efe-8cab-b444921dd223 (view SPL)IDArubicin Hydrochloride InjectionprescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2015-06-155007034154, 007034155, 007034156
5e6b1716d-71ea-4e2b-996d-67ec40759672 (view SPL)Idarubicin Hydrochloride Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-08-102633230194

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