Daunorubicin Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Parenteral Medicines, Inc (2012-12-20)
Oldest Current Product
2004-04-01
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\DAUNORUBICIN
FDAOB
INJECTION\INJECTION\DAUNORUBICIN HYDROCHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\DAUNORUBICIN HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\DAUNORUBICIN

product(s) by strength(s)

daunorubicin 5 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007035233ANDATeva Parenteral Medicines, Inc2004-04-01DAUNORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA06503529fe455e-f177-4b0e-99fb-60a53016db72, 4b8a5ad9-9e34-4f88-997c-244d9a0ef2c2

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA061876CERUBIDINETrueSANOFI AVENTIS US LLCANDA061876_001
2ANDA064103CERUBIDINEEUROHEALTH INTERNATIONAL SARL1995-02-03ANDA064103_001
3ANDA064212DAUNORUBICIN HYDROCHLORIDETrueTEVA PARENTERAL MEDICINES INC1998-06-23ANDA064212_001, ANDA064212_002
4ANDA065000DAUNORUBICIN HYDROCHLORIDEFRESENIUS KABI USA LLC1999-05-25ANDA065000_001
5ANDA065034DAUNORUBICIN HYDROCHLORIDEFRESENIUS KABI USA LLC2001-11-20ANDA065034_001
6ANDA065035DAUNORUBICIN HYDROCHLORIDETEVA PHARMACEUTICALS USA2000-01-24ANDA065035_001
7NDA050484CERUBIDINETrueWYETH AYERST RESEARCHNDA050484_001
8NDA050731DAUNORUBICIN HYDROCHLORIDEEUROHEALTH INTERNATIONAL SARL1998-01-30NDA050731_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA061876_001discontinuedDAUNORUBICIN HYDROCHLORIDE (EQ 20MG BASE/VIAL)INJECTIONFalseCERUBIDINE
2ANDA064103_001RXDAUNORUBICIN HYDROCHLORIDE (EQ 20MG BASE/VIAL)INJECTIONTrueAP1995-02-03CERUBIDINE
3ANDA064212_001discontinuedDAUNORUBICIN HYDROCHLORIDE (EQ 20MG BASE/VIAL)INJECTIONFalse1998-06-23DAUNORUBICIN HYDROCHLORIDE
4ANDA064212_002discontinuedDAUNORUBICIN HYDROCHLORIDE (EQ 50MG BASE/VIAL)INJECTIONFalse1999-05-03DAUNORUBICIN HYDROCHLORIDE
5ANDA065000_001RXDAUNORUBICIN HYDROCHLORIDE (EQ 20MG BASE/VIAL)INJECTIONFalseAP1999-05-25DAUNORUBICIN HYDROCHLORIDE
6ANDA065034_001RXDAUNORUBICIN HYDROCHLORIDE (EQ 5MG BASE/VIAL)INJECTIONFalse2001-11-20DAUNORUBICIN HYDROCHLORIDE
7ANDA065035_001RXDAUNORUBICIN HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONFalseAP2000-01-24DAUNORUBICIN HYDROCHLORIDE
8NDA050484_001discontinuedDAUNORUBICIN HYDROCHLORIDE (EQ 20MG BASE/VIAL)INJECTIONFalseCERUBIDINE
9NDA050731_001RXDAUNORUBICIN HYDROCHLORIDE (EQ 5MG BASE/ML)INJECTIONTrueAP1998-01-30DAUNORUBICIN HYDROCHLORIDE

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
129fe455e-f177-4b0e-99fb-60a53016db72 (view SPL)DAUNORUBICIN Hydrochloride InjectionprescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2012-12-174007035233
24b8a5ad9-9e34-4f88-997c-244d9a0ef2c2 (view SPL)DAUNORUBICIN Hydrochloride InjectionprescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2012-12-201007035233

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