Bleomycin Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
App Pharmaceuticals, Llc (2014-09-30)
Oldest Current Product
2000-03-10
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\BLEOMYCIN
FDAOB
INJECTION\INJECTION\BLEOMYCIN SULFATE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\BLEOMYCIN SULFATE
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\BLEOMYCIN

product(s) by strength(s)

bleomycin 15 unt/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007033154ANDATeva Parenteral Medicines, Inc2000-06-30BLEOMYCIN SULFATEINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0650332ef2901b-e3ee-47ba-81d9-48c6668fd19b
2007033155ANDATeva Parenteral Medicines, Inc2000-06-30BLEOMYCIN SULFATEINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0650332ef2901b-e3ee-47ba-81d9-48c6668fd19b
3617030323ANDAHospira Worldwide, Inc.2000-03-10BLEOMYCIN SULFATEINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA065031905e0984-2ce3-481c-b1a0-0ef0a616479a
4617030332ANDAHospira Worldwide, Inc.2000-03-10BLEOMYCIN SULFATEINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA065031905e0984-2ce3-481c-b1a0-0ef0a616479a
5633230136ANDAApp Pharmaceuticals, Llc2009-02-13BLEOMYCIN SULFATEINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA065185b5806c40-12ce-48e3-8abd-9f8997ef4428
6633230137ANDAApp Pharmaceuticals, Llc2009-02-13BLEOMYCIN SULFATEINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA065185b5806c40-12ce-48e3-8abd-9f8997ef4428

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA064084BLEOMYCIN SULFATETrueTEVA PARENTERAL MEDICINES INC1996-06-01ANDA064084_001, ANDA064084_002
2ANDA065031BLEOMYCIN SULFATEHOSPIRA INC2000-03-10ANDA065031_001, ANDA065031_002
3ANDA065033BLEOMYCIN SULFATETEVA PHARMACEUTICALS USA2000-06-27ANDA065033_001, ANDA065033_002
4ANDA065042BLEOMYCIN SULFATEEUROHEALTH INTERNATIONAL SARL2001-10-17ANDA065042_001, ANDA065042_002
5ANDA065185BLEOMYCIN SULFATEFRESENIUS KABI USA LLC2008-01-28ANDA065185_001, ANDA065185_002
6ANDA065201BLEOMYCIN SULFATETruePHARMACHEMIE BV2007-12-13ANDA065201_001
7NDA050443BLENOXANETrueBRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTENDA050443_001, NDA050443_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA064084_001discontinuedBLEOMYCIN SULFATE (EQ 15 UNITS BASE/VIAL)INJECTIONFalse1996-06-01BLEOMYCIN SULFATE
2ANDA064084_002discontinuedBLEOMYCIN SULFATE (EQ 30 UNITS BASE/VIAL)INJECTIONFalse1996-06-01BLEOMYCIN SULFATE
3ANDA065031_001RXBLEOMYCIN SULFATE (EQ 15 UNITS BASE/VIAL)INJECTIONFalseAP2000-03-10BLEOMYCIN SULFATE
4ANDA065031_002RXBLEOMYCIN SULFATE (EQ 30 UNITS BASE/VIAL)INJECTIONFalseAP2000-03-10BLEOMYCIN SULFATE
5ANDA065033_001RXBLEOMYCIN SULFATE (EQ 15 UNITS BASE/VIAL)INJECTIONFalseAP2000-06-27BLEOMYCIN SULFATE
6ANDA065033_002RXBLEOMYCIN SULFATE (EQ 30 UNITS BASE/VIAL)INJECTIONFalseAP2000-06-27BLEOMYCIN SULFATE
7ANDA065042_001RXBLEOMYCIN SULFATE (EQ 30 UNITS BASE/VIAL)INJECTIONFalseAP2001-10-17BLEOMYCIN SULFATE
8ANDA065042_002RXBLEOMYCIN SULFATE (EQ 15 UNITS BASE/VIAL)INJECTIONFalseAP2001-10-17BLEOMYCIN SULFATE
9ANDA065185_001RXBLEOMYCIN SULFATE (EQ 15 UNITS BASE/VIAL)INJECTIONTrueAP2008-01-28BLEOMYCIN SULFATE
10ANDA065185_002RXBLEOMYCIN SULFATE (EQ 30 UNITS BASE/VIAL)INJECTIONTrueAP2008-01-28BLEOMYCIN SULFATE
11ANDA065201_001discontinuedBLEOMYCIN SULFATE (EQ 15 UNITS BASE/VIAL)INJECTIONFalse2007-12-13BLEOMYCIN SULFATE
12NDA050443_001discontinuedBLEOMYCIN SULFATE (EQ 15 UNITS BASE/VIAL)INJECTIONFalseBLENOXANE
13NDA050443_002discontinuedBLEOMYCIN SULFATE (EQ 30 UNITS BASE/VIAL)INJECTIONFalse1995-09-07BLENOXANE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12ef2901b-e3ee-47ba-81d9-48c6668fd19b (view SPL)Bleomycin for Injection USPprescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2013-04-044007033154, 007033155
2905e0984-2ce3-481c-b1a0-0ef0a616479a (view SPL)BleomycinprescriptionHuman PrescriptionHospira Worldwide, Inc.2013-11-1213617030323, 617030332
3b5806c40-12ce-48e3-8abd-9f8997ef4428 (view SPL)Bleomycin for Injeciton USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-09-304633230136, 633230137

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