Colistin Injectable Solution

Brand(s)
Coly Mycin M
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Par Pharmaceutical Inc. (2015-11-06)
Oldest Current Product
2004-03-20
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
INJECTABLE SOLUTION\COLISTIN
FDAOB
INJECTION\INJECTION\COLISTIMETHATE SODIUM\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\COLISTIMETHATE SODIUM
INTRAMUSCULAR\INJECTION\COLISTIMETHATE
INTRAMUSCULAR\INJECTION\COLISTIMETHATE SODIUM
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\COLISTIMETHATE
INTRAMUSCULAR\INJECTION\COLISTIMETHATE
INTRAMUSCULAR\INJECTION\COLISTIN

product(s) by strength(s)

colistin 75 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1420230107Coly Mycin MNDAPar Pharmaceutical Inc.2007-11-01COLISTIMETHATE SODIUMINTRAMUSCULARINJECTIONNDA0501086d6e13e2-dc33-4b7b-84d0-66146a57c552

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005740858ANDAPaddock Laboratories, Llc2004-03-20COLISTIMETHATE SODIUMINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA06517791c7f6d0-d056-42de-9f0b-97e30c1279f9
2250210159ANDASagent Pharmaceuticals2014-12-29COLISTIMETHATE SODIUMINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA20136544c6c959-feaf-41a9-8d8c-0290ff445647
3398220615ANDAX-Gen Pharmaceuticals, Inc.2011-01-01COLISTIMETHATE SODIUMINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA064216ac75c6ee-e8eb-4bad-91d5-a58e64ba5d60
4420230131NDA AUTHORIZED GENERICPar Pharmaceutical Inc.2012-06-01COLISTIMETHATE SODIUMINTRAMUSCULARINJECTIONNDA050108dddcd6e6-09dd-4523-802e-21765e7abb5d
5459320023ANDAXellia Pharmaceuticals Aps2012-11-22COLISTIMETHATEINTRAMUSCULARINJECTIONANDA20535694bd9798-5d36-48d0-924b-319662c97e8c
6633230393ANDAApp Pharmaceuticals, Llc2009-12-04COLISTIMETHATE SODIUMINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA065364ab241809-0d2f-44ba-829c-26be67ee623f

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA064216COLISTIMETHATE SODIUMX GEN PHARMACEUTICALS INC1999-02-26ANDA064216_001
2ANDA065177COLISTIMETHATE SODIUMPADDOCK LABORATORIES LLC2004-03-19ANDA065177_001
3ANDA065364COLISTIMETHATE SODIUMFRESENIUS KABI USA LLC2008-04-17ANDA065364_001
4ANDA201365COLISTIMETHATE SODIUMSAGENT PHARMACEUTICALS INC2014-02-19ANDA201365_001
5ANDA202359COLISTIMETHATE SODIUMEMCURE PHARMACEUTICALS LTD2012-09-28ANDA202359_001
6ANDA205356COLISTIMETHATE SODIUMXELLIA PHARMACEUTICALS APS2015-05-29ANDA205356_001
7NDA050108COLY-MYCIN MPAR STERILE PRODUCTS LLCNDA050108_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA064216_001RXCOLISTIMETHATE SODIUM (EQ 150MG BASE/VIAL)INJECTIONFalseAP1999-02-26COLISTIMETHATE SODIUM
2ANDA065177_001RXCOLISTIMETHATE SODIUM (EQ 150MG BASE/VIAL)INJECTIONFalseAP2004-03-19COLISTIMETHATE SODIUM
3ANDA065364_001RXCOLISTIMETHATE SODIUM (EQ 150MG BASE/VIAL)INJECTIONFalseAP2008-04-17COLISTIMETHATE SODIUM
4ANDA201365_001RXCOLISTIMETHATE SODIUM (EQ 150MG BASE/VIAL)INJECTIONFalseAP2014-02-19COLISTIMETHATE SODIUM
5ANDA202359_001RXCOLISTIMETHATE SODIUM (EQ 150MG BASE/VIAL)INJECTIONFalseAP2012-09-28COLISTIMETHATE SODIUM
6ANDA205356_001RXCOLISTIMETHATE SODIUM (EQ 150MG BASE/VIAL)INJECTIONFalseAP2015-05-29COLISTIMETHATE SODIUM
7NDA050108_002RXCOLISTIMETHATE SODIUM (EQ 150MG BASE/VIAL)INJECTIONTrueAPCOLY-MYCIN M

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
144c6c959-feaf-41a9-8d8c-0290ff445647 (view SPL)Colistimethate for Injection, USPprescriptionHuman PrescriptionSagent Pharmaceuticals2014-12-296250210159
26d6e13e2-dc33-4b7b-84d0-66146a57c552 (view SPL)Coly-Mycin M Parenteral (Colistimethate for Injection, USP)prescriptionHuman PrescriptionPar Pharmaceutical Inc.2013-04-018420230107
391c7f6d0-d056-42de-9f0b-97e30c1279f9 (view SPL)Colistimethate For Injection, USPprescriptionHuman PrescriptionPaddock Laboratories, Llc2013-10-146005740858
494bd9798-5d36-48d0-924b-319662c97e8c (view SPL)Colistimethate for Injection, USPprescriptionHuman PrescriptionXellia Pharmaceuticals ApsMANUFACTURE2015-11-244459320023
5ab241809-0d2f-44ba-829c-26be67ee623f (view SPL)Colistimethate for Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2013-07-032633230393
6ac75c6ee-e8eb-4bad-91d5-a58e64ba5d60 (view SPL)Colistimethate for Injection, USPRx Only FOR INTRAMUSCULAR AND INTRAVENOUS USEprescriptionHuman PrescriptionX-Gen Pharmaceuticals, Inc.2015-04-1522398220615
7dddcd6e6-09dd-4523-802e-21765e7abb5d (view SPL)Colistimethate for Injection, USPprescriptionHuman PrescriptionPar Pharmaceutical Inc.2015-11-065420230131

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