Doxorubicin Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pfizer Labs (2015-11-20)
Oldest Current Product
1987-12-23
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\DOXORUBICIN
FDAOB
INJECTION\INJECTION\DOXORUBICIN HYDROCHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\DOXORUBICIN HYDROCHLORIDE
INTRAVENOUS\INJECTION, SOLUTION\DOXORUBICIN HYDROCHLORIDE
INTRAVENOUS\INJECTION\DOXORUBICIN HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\DOXORUBICIN
INTRAVENOUS\INJECTION, SOLUTION\DOXORUBICIN
INTRAVENOUS\INJECTION\DOXORUBICIN

product(s) by strength(s)

doxorubicin hydrochloride 2 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000693032NDAPfizer Labs1987-12-23DOXORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA0506291fd148fb-0fbc-4b6f-b790-23546fb46a71
2000693033NDAPfizer Labs1987-12-23DOXORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA0506291fd148fb-0fbc-4b6f-b790-23546fb46a71
3000693034NDAPfizer Labs1987-12-23DOXORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA0506291fd148fb-0fbc-4b6f-b790-23546fb46a71
4000694026NDAPfizer Labs2014-03-17DOXORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA05062900634b2b-4e48-4178-8877-28582af894ad
5000694030NDAPfizer Labs2013-03-05DOXORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA050629201037df-9a76-4d0b-9c2b-aba6b74e8dc2
6000694032NDAPfizer Labs2013-03-05DOXORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA050629201037df-9a76-4d0b-9c2b-aba6b74e8dc2
7000694034NDAPfizer Labs2013-03-05DOXORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA050629201037df-9a76-4d0b-9c2b-aba6b74e8dc2

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690170ANDAPfizer Labs2011-10-29DOXORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA200170b4a04cb3-5301-4bbb-9544-43e2e778ecd3
2007035040ANDATeva Parenteral Medicines, Inc1996-09-01DOXORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA064140102358dc-2109-4829-b333-b99417334e39
3007035043ANDATeva Parenteral Medicines, Inc1995-09-01DOXORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA064140102358dc-2109-4829-b333-b99417334e39
4007035046ANDATeva Parenteral Medicines, Inc1995-09-01DOXORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA064140102358dc-2109-4829-b333-b99417334e39
5250210207ANDASagent Pharmaceuticals2013-10-31DOXORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA091495ae80bd3a-b99a-4e01-a444-b9d05687f00e
6459630733ANDAActavis Inc.2014-11-01DOXORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA20362233ddfdb1-b4bc-464d-a186-49c4b156279f
7531500314ANDAAmneal-Agila, Llc2013-04-30DOXORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTIONANDA200901939cfd5f-a496-43b3-a883-dbf4651310d4
8531500315ANDAAmneal-Agila, Llc2013-04-30DOXORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTIONANDA200901939cfd5f-a496-43b3-a883-dbf4651310d4
9531500317ANDAAmneal-Agila, Llc2013-04-30DOXORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTIONANDA200901939cfd5f-a496-43b3-a883-dbf4651310d4
10531500320ANDAAmneal-Agila, Llc2013-04-30DOXORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTIONANDA200901939cfd5f-a496-43b3-a883-dbf4651310d4
11627560826ANDASun Pharmaceutical Industries Limited2012-02-20DOXORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA0914186bcde92b-e584-4919-866a-68847ea201ba
12627560827ANDASun Pharmaceutical Industries Limited2012-02-20DOXORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA0914186bcde92b-e584-4919-866a-68847ea201ba
13633230101ANDAApp Pharmaceuticals, Llc2000-06-14DOXORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA063277e0349f98-42fa-4003-b6d8-a1db1401b0ef
14633230883ANDAApp Pharmaceuticals, Llc2000-04-14DOXORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA063277e0349f98-42fa-4003-b6d8-a1db1401b0ef
15674570393ANDAMylan Institutional Llc2012-02-14DOXORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTIONANDA200901c40405d1-e70c-40d3-be44-f6815b1fe45a
16674570478ANDAMylan Institutional Llc2011-10-29DOXORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA2001705f71f79a-4f14-472d-b982-e28c3ce8f972

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA062921DOXORUBICIN HYDROCHLORIDEEUROHEALTH INTERNATIONAL SARL1989-03-17ANDA062921_001, ANDA062921_002, ANDA062921_003
2ANDA062926RUBEXTrueBRISTOL MYERS SQUIBB CO1989-04-13ANDA062926_001, ANDA062926_002, ANDA062926_003
3ANDA062975DOXORUBICIN HYDROCHLORIDEEUROHEALTH INTERNATIONAL SARL1989-03-17ANDA062975_001
4ANDA063097DOXORUBICIN HYDROCHLORIDEPHARMACHEMIE BV1990-05-21ANDA063097_001, ANDA063097_002, ANDA063097_003
5ANDA063165ADRIAMYCIN PFSTruePHARMACIA AND UPJOHN CO1991-01-30ANDA063165_001, ANDA063165_002
6ANDA063277DOXORUBICIN HYDROCHLORIDEFRESENIUS KABI USA LLC1995-10-26ANDA063277_001
7ANDA063336DOXORUBICIN HYDROCHLORIDEPHARMACHEMIE BV1995-02-28ANDA063336_001, ANDA063336_004
8ANDA064097DOXORUBICIN HYDROCHLORIDEEUROHEALTH INTERNATIONAL SARL1994-09-13ANDA064097_001
9ANDA064140DOXORUBICIN HYDROCHLORIDETEVA PHARMACEUTICALS USA1995-07-28ANDA064140_001, ANDA064140_002
10ANDA065515DOXORUBICIN HYDROCHLORIDEALVOGEN INC2012-11-08ANDA065515_001
11ANDA091418DOXORUBICIN HYDROCHLORIDESUN PHARMACEUTICAL INDUSTRIES LTD2012-02-15ANDA091418_001
12ANDA091495DOXORUBICIN HYDROCHLORIDESAGENT PHARMACEUTICALS INC2013-03-18ANDA091495_001
13ANDA200146DOXORUBICIN HYDROCHLORIDESANDOZ INC2012-07-18ANDA200146_001
14ANDA200170DOXORUBICIN HYDROCHLORIDEMYLAN LABORATORIES LTD2011-10-28ANDA200170_001, ANDA200170_002
15ANDA200901DOXORUBICIN HYDROCHLORIDEMYLAN LABORATORIES LTD2012-02-14ANDA200901_001
16ANDA203622DOXORUBICIN HYDROCHLORIDEACTAVIS INC2014-06-27ANDA203622_001
17NDA050467DOXORUBICIN HYDROCHLORIDETruePHARMACIA AND UPJOHN CONDA050467_001, NDA050467_002, NDA050467_003, NDA050467_004
18NDA050629DOXORUBICIN HYDROCHLORIDEPHARMACIA AND UPJOHN CO1987-12-23NDA050629_001, NDA050629_002, NDA050629_003

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA062921_001RXDOXORUBICIN HYDROCHLORIDE (10MG/VIAL)INJECTIONTrueAP1989-03-17DOXORUBICIN HYDROCHLORIDE
2ANDA062921_002RXDOXORUBICIN HYDROCHLORIDE (20MG/VIAL)INJECTIONTrueAP1989-03-17DOXORUBICIN HYDROCHLORIDE
3ANDA062921_003RXDOXORUBICIN HYDROCHLORIDE (50MG/VIAL)INJECTIONTrueAP1989-03-17DOXORUBICIN HYDROCHLORIDE
4ANDA062926_001discontinuedDOXORUBICIN HYDROCHLORIDE (10MG/VIAL)INJECTIONFalse1989-04-13RUBEX
5ANDA062926_002discontinuedDOXORUBICIN HYDROCHLORIDE (50MG/VIAL)INJECTIONFalse1989-04-13RUBEX
6ANDA062926_003discontinuedDOXORUBICIN HYDROCHLORIDE (100MG/VIAL)INJECTIONFalse1989-04-13RUBEX
7ANDA062975_001RXDOXORUBICIN HYDROCHLORIDE (2MG/ML)INJECTIONTrueAP1989-03-17DOXORUBICIN HYDROCHLORIDE
8ANDA063097_001RXDOXORUBICIN HYDROCHLORIDE (10MG/VIAL)INJECTIONFalseAP1990-05-21DOXORUBICIN HYDROCHLORIDE
9ANDA063097_002RXDOXORUBICIN HYDROCHLORIDE (20MG/VIAL)INJECTIONFalseAP1990-05-21DOXORUBICIN HYDROCHLORIDE
10ANDA063097_003RXDOXORUBICIN HYDROCHLORIDE (50MG/VIAL)INJECTIONFalseAP1990-05-21DOXORUBICIN HYDROCHLORIDE
11ANDA063165_001discontinuedDOXORUBICIN HYDROCHLORIDE (2MG/ML)INJECTIONFalse1991-01-30ADRIAMYCIN PFS
12ANDA063165_002discontinuedDOXORUBICIN HYDROCHLORIDE (200MG/100ML)INJECTIONFalse1991-01-30ADRIAMYCIN PFS
13ANDA063277_001RXDOXORUBICIN HYDROCHLORIDE (2MG/ML)INJECTIONFalseAP1995-10-26DOXORUBICIN HYDROCHLORIDE
14ANDA063336_001RXDOXORUBICIN HYDROCHLORIDE (2MG/ML)INJECTIONFalseAP1995-02-28DOXORUBICIN HYDROCHLORIDE
15ANDA063336_004RXDOXORUBICIN HYDROCHLORIDE (200MG/100ML)INJECTIONFalseAP1995-02-28DOXORUBICIN HYDROCHLORIDE
16ANDA064097_001RXDOXORUBICIN HYDROCHLORIDE (200MG/100ML)INJECTIONTrueAP1994-09-13DOXORUBICIN HYDROCHLORIDE
17ANDA064140_001RXDOXORUBICIN HYDROCHLORIDE (2MG/ML)INJECTIONFalseAP1995-07-28DOXORUBICIN HYDROCHLORIDE
18ANDA064140_002RXDOXORUBICIN HYDROCHLORIDE (200MG/100ML)INJECTIONFalseAP1995-07-28DOXORUBICIN HYDROCHLORIDE
19ANDA065515_001RXDOXORUBICIN HYDROCHLORIDE (2MG/ML)INJECTIONFalseAP2012-11-08DOXORUBICIN HYDROCHLORIDE
20ANDA091418_001RXDOXORUBICIN HYDROCHLORIDE (2MG/ML)INJECTIONFalseAP2012-02-15DOXORUBICIN HYDROCHLORIDE
21ANDA091495_001RXDOXORUBICIN HYDROCHLORIDE (2MG/ML)INJECTIONFalseAP2013-03-18DOXORUBICIN HYDROCHLORIDE
22ANDA200146_001RXDOXORUBICIN HYDROCHLORIDE (2MG/ML)INJECTIONFalseAP2012-07-18DOXORUBICIN HYDROCHLORIDE
23ANDA200170_001RXDOXORUBICIN HYDROCHLORIDE (10MG/VIAL)INJECTIONFalseAP2011-10-28DOXORUBICIN HYDROCHLORIDE
24ANDA200170_002RXDOXORUBICIN HYDROCHLORIDE (50MG/VIAL)INJECTIONFalseAP2011-10-28DOXORUBICIN HYDROCHLORIDE
25ANDA200901_001RXDOXORUBICIN HYDROCHLORIDE (2MG/ML)INJECTIONFalseAP2012-02-14DOXORUBICIN HYDROCHLORIDE
26ANDA203622_001RXDOXORUBICIN HYDROCHLORIDE (2MG/ML)INJECTIONFalseAP2014-06-27DOXORUBICIN HYDROCHLORIDE
27NDA050467_001discontinuedDOXORUBICIN HYDROCHLORIDE (10MG/VIAL)INJECTIONFalseDOXORUBICIN HYDROCHLORIDE
28NDA050467_002discontinuedDOXORUBICIN HYDROCHLORIDE (50MG/VIAL)INJECTIONFalseDOXORUBICIN HYDROCHLORIDE
29NDA050467_003discontinuedDOXORUBICIN HYDROCHLORIDE (20MG/VIAL)INJECTIONFalse1985-05-20DOXORUBICIN HYDROCHLORIDE
30NDA050467_004discontinuedDOXORUBICIN HYDROCHLORIDE (150MG/VIAL)INJECTIONFalse1987-07-22DOXORUBICIN HYDROCHLORIDE
31NDA050629_001RXDOXORUBICIN HYDROCHLORIDE (2MG/ML)INJECTIONTrueAP1987-12-23DOXORUBICIN HYDROCHLORIDE
32NDA050629_002RXDOXORUBICIN HYDROCHLORIDE (200MG/100ML)INJECTIONTrueAP1988-05-03DOXORUBICIN HYDROCHLORIDE
33NDA050629_003RXDOXORUBICIN HYDROCHLORIDE (150MG/75ML)INJECTIONFalse2011-03-28DOXORUBICIN HYDROCHLORIDE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
100634b2b-4e48-4178-8877-28582af894ad (view SPL)These highlights do not include all the information needed to use DOXORUBICIN HYDROCHLORIDE safely and effectively. See full prescribing information for DOXORUBICIN HYDROCHLORIDE. DOXORUBICIN HYDROCHLORIDE injection, for intravenous useInitial U.S. Approval: 1974prescriptionHuman PrescriptionPfizer LabsAPI MANUFACTURE, MANUFACTURE, PACK2013-11-012000694026, 000694004, 000694015, 000694037
2102358dc-2109-4829-b333-b99417334e39 (view SPL)These highlights do not include all the information needed to use DOXORUBICIN hydrochloride injection USP safely and effectively. See full prescribing information for DOXORUBICIN hydrochloride injection USP.DOXORUBICIN hydrochloride injection USP, for intravenous use Initial U.S. Approval: 1974prescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2014-02-106007035040, 007035043, 007035046
31fd148fb-0fbc-4b6f-b790-23546fb46a71 (view SPL)These highlights do not include all the information needed to use DOXORUBICIN HYDROCHLORIDE safely and effectively. See full prescribing information for DOXORUBICIN HYDROCHLORIDE. DOXORUBICIN HYDROCHLORIDE injection, for intravenous useDOXORUBICIN HYDROCHLORIDE for injection, for intravenous useInitial U.S. Approval: 1974prescriptionHuman PrescriptionPfizer LabsANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2014-11-1311000693032, 000693033, 000693034, 000693030, 000693031
4201037df-9a76-4d0b-9c2b-aba6b74e8dc2 (view SPL)These highlights do not include all the information needed to use DOXORUBICIN HYDROCHLORIDE safely and effectively. See full prescribing information for DOXORUBICIN HYDROCHLORIDE. DOXORUBICIN HYDROCHLORIDE injection, for intravenous useInitial U.S. Approval: 1974prescriptionHuman PrescriptionPfizer LabsANALYSIS, API MANUFACTURE, MANUFACTURE2015-11-203000694030, 000694032, 000694034, 000694031, 000694033
533ddfdb1-b4bc-464d-a186-49c4b156279f (view SPL)DOXOrubicin Hydrochloride Injection, USPprescriptionHuman PrescriptionActavis Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-06-014459630733
65f71f79a-4f14-472d-b982-e28c3ce8f972 (view SPL)These highlights do not include all the information needed to use Doxorubicin hydrochloride for injection, USP safely and effectively. See full prescribing information for Doxorubicin hydrochloride for injection, USP.DOXORUBICIN hydrochloride for injection, USP for intravenous useInitial U.S. Approval: 1974prescriptionHuman PrescriptionMylan Institutional LlcAnalysis, Label, Manufacture, Pack, Sterilize2014-05-292674570478
76bcde92b-e584-4919-866a-68847ea201ba (view SPL)These highlights do not include all the information needed to use doxorubicin hydrochloride safely and effectively. See full prescribing information for doxorubicin hydrochloride injection.DOXORUBICIN hydrochloride injection, USP for intravenous useInitial U.S. Approval: 1974prescriptionHuman PrescriptionSun Pharmaceutical Industries LimitedANALYSIS, MANUFACTURE2015-05-073627560826, 627560827
8939cfd5f-a496-43b3-a883-dbf4651310d4 (view SPL)DOXOrubicin Hydrochloride Injection, USP For Intravenous Use Only Rx ONLYprescriptionHuman PrescriptionAmneal-Agila, Llc2012-12-281531500314, 531500315, 531500317, 531500320
9ae80bd3a-b99a-4e01-a444-b9d05687f00e (view SPL)These highlights do not include all the information needed to use Doxorubicin Hydrochloride Injection, USP safely and effectively. See full prescribing information for Doxorubicin Hydrochloride Injection, USP. Doxorubicin Hydrochloride Injection, USP, for intravenous use Initial U.S. Approval: 1974prescriptionHuman PrescriptionSagent Pharmaceuticals2014-01-2810250210207
10b4a04cb3-5301-4bbb-9544-43e2e778ecd3 (view SPL)Doxorubicin for Injection, USPprescriptionHuman PrescriptionPfizer LabsAnalysis, Manufacture, Pack, Sterilize2012-05-151000690170
11c40405d1-e70c-40d3-be44-f6815b1fe45a (view SPL)These highlights do not include all the information needed to use DOXORUBICIN hydrochloride injection, USP safely and effectively. See full prescribing information for DOXORUBICIN hydrochloride injection, USP.DOXORUBICIN hydrochloride injection, USP for intravenous useInitial U.S. Approval: 1974prescriptionHuman PrescriptionMylan Institutional LlcAnalysis, Label, Manufacture, Pack, Sterilize2014-07-022674570393
12e0349f98-42fa-4003-b6d8-a1db1401b0ef (view SPL)Doxorubicin Hydrochloride Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2013-07-162633230101, 633230883

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