Polymyxin B Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
X-Gen Pharmaceuticals, Inc. (2014-08-21)
Oldest Current Product
1994-09-30
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\POLYMYXIN B
FDAOB
INJECTION\INJECTION\POLYMYXIN B SULFATE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\POLYMYXIN B SULFATE
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\POLYMYXIN B SULFATE
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\POLYMYXIN B
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\POLYMYXIN B

product(s) by strength(s)

polymyxin b 250000 unt/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1250210117ANDASagent Pharmaceuticals2011-08-01POLYMYXIN B SULFATEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA0901104d74fba7-ffbf-4462-830a-e6b6f7d35266
2398220166ANDAX-Gen Pharmaceuticals, Inc.1994-09-30POLYMYXIN B SULFATEINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA063000a14373aa-c5fa-4f90-8e8f-fc9e2219039c
3398220170ANDAX-Gen Pharmaceuticals, Inc.2014-01-15POLYMYXIN B SULFATEINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA202766caeee003-cfdc-4b57-a88b-5391ed7e73e5
4398220171ANDAX-Gen Pharmaceuticals, Inc.2014-04-25POLYMYXIN B SULFATEINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA202766805caef0-89df-4bcf-876d-9f6b7a89c9a3
5633230321ANDAApp Pharmaceuticals, Llc2009-11-17POLYMYXIN B SULFATEINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA065372fbc12c18-567b-41bc-89d0-efd29616615c
6633230367ANDAApp Pharmaceuticals, Llc2015-09-09POLYMYXIN B SULFATEINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA2027661d57c007-5019-4f88-a927-4a186c25d912

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA060716POLYMYXIN B SULFATEEUROHEALTH INTERNATIONAL SARLANDA060716_001
2ANDA062036AEROSPORINTrueGLAXOSMITHKLINEANDA062036_001
3ANDA063000POLYMYXIN B SULFATEX GEN PHARMACEUTICALS INC1994-09-30ANDA063000_001
4ANDA065372POLYMYXIN B SULFATEFRESENIUS KABI USA LLC2008-01-10ANDA065372_001
5ANDA090110POLYMYCIN B SULFATESAGENT STRIDES LLC2011-06-29ANDA090110_001
6ANDA202766POLYMYXIN B SULFATEXELLIA PHARMACEUTICALS APS2014-01-15ANDA202766_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA060716_001RXPOLYMYXIN B SULFATE (EQ 500,000 UNITS BASE/VIAL)INJECTIONTrueAPPOLYMYXIN B SULFATE
2ANDA062036_001discontinuedPOLYMYXIN B SULFATE (EQ 500,000 U BASE/VIAL)INJECTIONFalseAEROSPORIN
3ANDA063000_001RXPOLYMYXIN B SULFATE (EQ 500,000 UNITS BASE/VIAL)INJECTIONFalseAP1994-09-30POLYMYXIN B SULFATE
4ANDA065372_001RXPOLYMYXIN B SULFATE (EQ 500,000 UNITS BASE/VIAL)INJECTIONFalseAP2008-01-10POLYMYXIN B SULFATE
5ANDA090110_001RXPOLYMYXIN B SULFATE (EQ 500,000 UNITS BASE/VIAL)INJECTIONFalseAP2011-06-29POLYMYCIN B SULFATE
6ANDA202766_001RXPOLYMYXIN B SULFATE (EQ 500,000 UNITS BASE/VIAL)INJECTIONFalseAP2014-01-15POLYMYXIN B SULFATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11d57c007-5019-4f88-a927-4a186c25d912 (view SPL)Polymyxin B for Injection USP 500,000 Units Rx Only To reduce the development of drug-resistant bacteria and maintain the effectiveness of polymyxin B and other antibacterial drugs, polymyxin B should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-09-091633230367
24d74fba7-ffbf-4462-830a-e6b6f7d35266 (view SPL)Polymyxin B for Injection, USP 500,000 unitsprescriptionHuman PrescriptionSagent Pharmaceuticals2013-01-109250210117
3805caef0-89df-4bcf-876d-9f6b7a89c9a3 (view SPL)POLYMYXIN B FOR INJECTION, USP For Parenteral and Opthalmic AdministrationprescriptionHuman PrescriptionX-Gen Pharmaceuticals, Inc.2015-04-212398220171
4a14373aa-c5fa-4f90-8e8f-fc9e2219039c (view SPL)POLYMYXIN B FOR INJECTION, USP For Parenteral and Opthalmic AdministrationprescriptionHuman PrescriptionX-Gen Pharmaceuticals, Inc.2014-08-2116398220166
5caeee003-cfdc-4b57-a88b-5391ed7e73e5 (view SPL)POLYMYXIN B FOR INJECTION, USP For Parenteral and Opthalmic AdministrationprescriptionHuman PrescriptionX-Gen Pharmaceuticals, Inc.2015-04-212398220170
6fbc12c18-567b-41bc-89d0-efd29616615c (view SPL)Polymyxin B for Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-12-122633230321

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