Mitomycin Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Accord Healthcare Inc. (2014-12-16)
Oldest Current Product
2009-06-10
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\MITOMYCIN
FDAOB
INJECTION\INJECTION\MITOMYCIN\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\MITOMYCIN
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\MITOMYCIN

product(s) by strength(s)

mitomycin 0.5 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1167290108ANDAAccord Healthcare Inc.2009-06-10MITOMYCININTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA064144ff676355-313d-4575-8f2f-e4a1e9527477
2167290115ANDAAccord Healthcare Inc.2009-06-18MITOMYCININTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA064144ff676355-313d-4575-8f2f-e4a1e9527477
3167290116ANDAAccord Healthcare Inc.2011-03-11MITOMYCININTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA064144ff676355-313d-4575-8f2f-e4a1e9527477
4167290246ANDAAccord Healthcare Inc.2013-05-03MITOMYCININTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA064144d80c6dc0-5f26-4d7a-a0f7-7698ab4f249a

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA062336MUTAMYCINTrueBRISTOL MYERS COANDA062336_001, ANDA062336_002, ANDA062336_003
2ANDA064106MITOMYCINTrueHOSPIRA INC1995-11-29ANDA064106_001
3ANDA064117MITOMYCINBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC1995-04-19ANDA064117_001, ANDA064117_002
4ANDA064144MITOMYCINACCORD HEALTHCARE INC1998-04-30ANDA064144_001, ANDA064144_002, ANDA064144_003
5ANDA064180MITOMYCINHIKMA MAPLE LTD1999-12-23ANDA064180_001, ANDA064180_002
6NDA050450MUTAMYCINTrueBRISTOL LABORATORIES INC DIV BRISTOL MYERS CONDA050450_001, NDA050450_002
7NDA050763MITOZYTREXTrueSUPERGEN INC2002-11-14NDA050763_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA062336_001discontinuedMITOMYCIN (5MG/VIAL)INJECTIONFalseMUTAMYCIN
2ANDA062336_002discontinuedMITOMYCIN (20MG/VIAL)INJECTIONFalseMUTAMYCIN
3ANDA062336_003discontinuedMITOMYCIN (40MG/VIAL)INJECTIONFalse1988-03-10MUTAMYCIN
4ANDA064106_001discontinuedMITOMYCIN (20MG/VIAL)INJECTIONFalse1995-11-29MITOMYCIN
5ANDA064117_001RXMITOMYCIN (5MG/VIAL)INJECTIONFalseAP1995-04-19MITOMYCIN
6ANDA064117_002RXMITOMYCIN (20MG/VIAL)INJECTIONFalseAP1995-04-19MITOMYCIN
7ANDA064144_001RXMITOMYCIN (5MG/VIAL)INJECTIONTrueAP1998-04-30MITOMYCIN
8ANDA064144_002RXMITOMYCIN (20MG/VIAL)INJECTIONTrueAP1998-04-30MITOMYCIN
9ANDA064144_003RXMITOMYCIN (40MG/VIAL)INJECTIONTrueAP2009-08-11MITOMYCIN
10ANDA064180_001RXMITOMYCIN (5MG/VIAL)INJECTIONFalseAP1999-12-23MITOMYCIN
11ANDA064180_002RXMITOMYCIN (20MG/VIAL)INJECTIONFalseAP1999-12-23MITOMYCIN
12NDA050450_001discontinuedMITOMYCIN (5MG/VIAL)INJECTIONFalseMUTAMYCIN
13NDA050450_002discontinuedMITOMYCIN (20MG/VIAL)INJECTIONFalseMUTAMYCIN
14NDA050763_001discontinuedMITOMYCIN (5MG/VIAL)INJECTIONFalse2002-11-14MITOZYTREX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1d80c6dc0-5f26-4d7a-a0f7-7698ab4f249a (view SPL)MITOMYCIN FOR INJECTION USP, 5 mg/vial NOVAPLUSprescriptionHuman PrescriptionAccord Healthcare Inc.MANUFACTURE, analysis2013-05-031167290246
2ff676355-313d-4575-8f2f-e4a1e9527477 (view SPL)MITOMYCIN FOR INJECTION USP, 5 mg/vial, 20 mg/vial and 40 mg/vialprescriptionHuman PrescriptionAccord Healthcare Inc.manufacture2014-12-164167290108, 167290115, 167290116

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