Dacarbazine Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira Worldwide, Inc. (2015-05-13)
Oldest Current Product
1998-08-27
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\DACARBAZINE
FDAOB
INJECTION\INJECTION\DACARBAZINE\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\DACARBAZINE
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\DACARBAZINE

product(s) by strength(s)

dacarbazine 10 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007035075ANDATeva Parenteral Medicines, Inc1998-08-27DACARBAZINEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA07525926e91082-7698-4680-beab-07c47802f0f9
2617030327ANDAHospira Worldwide, Inc.2001-10-18DACARBAZINEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA0759404c7e5795-feba-425d-7ca3-6cb2c3a1c43c
3633230127ANDAApp Pharmaceuticals, Llc2001-09-07DACARBAZINEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA075371b6b97e41-5f15-498c-abfb-d8443ea4d216
4633230128ANDAApp Pharmaceuticals, Llc2001-09-07DACARBAZINEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONANDA075371b6b97e41-5f15-498c-abfb-d8443ea4d216

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070962DACARBAZINETrueABRAXIS PHARMACEUTICAL PRODUCTS1986-08-28ANDA070962_001
2ANDA070990DACARBAZINETrueABRAXIS PHARMACEUTICAL PRODUCTS1986-08-28ANDA070990_001
3ANDA075259DACARBAZINETEVA PHARMACEUTICALS USA1998-08-27ANDA075259_001, ANDA075259_002
4ANDA075371DACARBAZINEFRESENIUS KABI USA LLC1999-08-27ANDA075371_001, ANDA075371_002
5ANDA075812DACARBAZINEEUROHEALTH INTERNATIONAL SARL2001-06-15ANDA075812_001, ANDA075812_002
6ANDA075940DACARBAZINEHOSPIRA INC2001-10-18ANDA075940_001
7NDA017575DTIC-DOMEBAYER HEALTHCARE PHARMACEUTICALS INCNDA017575_001, NDA017575_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA070962_001discontinuedDACARBAZINE (100MG/VIAL)INJECTIONFalse1986-08-28DACARBAZINE
2ANDA070990_001discontinuedDACARBAZINE (200MG/VIAL)INJECTIONFalse1986-08-28DACARBAZINE
3ANDA075259_001RXDACARBAZINE (500MG/VIAL)INJECTIONTrueAP2000-09-22DACARBAZINE
4ANDA075259_002RXDACARBAZINE (200MG/VIAL)INJECTIONFalseAP1998-08-27DACARBAZINE
5ANDA075371_001RXDACARBAZINE (100MG/VIAL)INJECTIONFalseAP1999-08-27DACARBAZINE
6ANDA075371_002RXDACARBAZINE (200MG/VIAL)INJECTIONFalseAP1999-08-27DACARBAZINE
7ANDA075812_001RXDACARBAZINE (200MG/VIAL)INJECTIONFalseAP2001-06-15DACARBAZINE
8ANDA075812_002RXDACARBAZINE (500MG/VIAL)INJECTIONFalseAP2002-10-31DACARBAZINE
9ANDA075940_001RXDACARBAZINE (200MG/VIAL)INJECTIONFalseAP2001-10-18DACARBAZINE
10NDA017575_001RXDACARBAZINE (100MG/VIAL)INJECTIONTrueAPDTIC-DOME
11NDA017575_002RXDACARBAZINE (200MG/VIAL)INJECTIONTrueAPDTIC-DOME

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
126e91082-7698-4680-beab-07c47802f0f9 (view SPL)Dacarbazine for Injection USPprescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2015-01-092007035075
24c7e5795-feba-425d-7ca3-6cb2c3a1c43c (view SPL)Dacarbazine for Injection, USPprescriptionHuman PrescriptionHospira Worldwide, Inc.2015-05-1311617030327
3b6b97e41-5f15-498c-abfb-d8443ea4d216 (view SPL)Dacarbazine for Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2012-09-041633230127, 633230128

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