Bacitracin Injectable Solution

Brand(s)
Baci-IM
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmacia And Upjohn Company (2014-09-03)
Oldest Current Product
1948-07-29
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\BACITRACIN
FDAOB
INJECTION\INJECTION\BACITRACIN\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\BACITRACIN
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\BACITRACIN A
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\BACITRACIN
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\BACITRACIN
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\BACITRACIN A
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\BACITRACIN

product(s) by strength(s)

bacitracin 5000 unt/ml injectable solution

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000090233ANDAPharmacia And Upjohn Company1948-07-29BACITRACIN AINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA0607332dc33e75-dc52-4a36-86b9-474faa9e0a9f, be306d60-553d-4b8c-8aad-539da646d8e9
2000090234ANDAPharmacia And Upjohn Company1948-07-29BACITRACININTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA060733746cdb33-65cb-49db-8642-5bdda7b30de6
3000090241ANDAPharmacia And Upjohn Company1948-07-29BACITRACIN AINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA0607331c6f3da0-7189-4e1c-9010-c48d51badd6c
4250210116ANDASagent Pharmaceuticals2010-08-10BACITRACININTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA090211f706d901-25ab-4486-a64d-b362470baecd
5398220277Baci-IMANDAX-Gen Pharmaceuticals, Inc.1997-05-09BACITRACININTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA064153accddb51-2ca2-4b92-a028-b3d92124015c
6398220278ANDAX-Gen Pharmaceuticals, Inc.2015-10-08BACITRACININTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA20317791c64e3b-83c8-4fce-87c3-7e035e65e270
7633230329ANDAApp Pharmaceuticals, Llc2003-01-28BACITRACININTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA065116a3d2f60c-d3e8-4ce8-92eb-d3044783e5dd

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA060282BACITRACINTruePFIZER LABORATORIES DIV PFIZER INCANDA060282_001
2ANDA060733BACITRACINPHARMACIA AND UPJOHN COANDA060733_001, ANDA060733_002
3ANDA064153BACIIMX GEN PHARMACEUTICALS INC1997-05-09ANDA064153_001
4ANDA065116BACITRACINFRESENIUS KABI USA LLC2002-12-03ANDA065116_001
5ANDA090211BACITRACINSAGENT STRIDES LLC2010-05-11ANDA090211_001
6ANDA203177BACITRACINXELLIA PHARMACEUTICALS APS2014-08-25ANDA203177_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA060282_001discontinuedBACITRACIN (50,000 UNITS/VIAL)INJECTIONFalseBACITRACIN
2ANDA060733_001RXBACITRACIN (10,000 UNITS/VIAL)INJECTIONFalseBACITRACIN
3ANDA060733_002RXBACITRACIN (50,000 UNITS/VIAL)INJECTIONTrueAPBACITRACIN
4ANDA064153_001RXBACITRACIN (50,000 UNITS/VIAL)INJECTIONFalseAP1997-05-09BACIIM
5ANDA065116_001RXBACITRACIN (50,000 UNITS/VIAL)INJECTIONFalseAP2002-12-03BACITRACIN
6ANDA090211_001RXBACITRACIN (50,000 UNITS/VIAL)INJECTIONFalseAP2010-05-11BACITRACIN
7ANDA203177_001RXBACITRACIN (50,000 UNITS/VIAL)INJECTIONFalseAP2014-08-25BACITRACIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11c6f3da0-7189-4e1c-9010-c48d51badd6c (view SPL)Bacitracin for Injection, USPprescriptionHuman PrescriptionPharmacia And Upjohn CompanyAPI MANUFACTURE, MANUFACTURE2013-11-011000090241
22dc33e75-dc52-4a36-86b9-474faa9e0a9f (view SPL)Bacitracin for Injection, USPprescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, MANUFACTURE2013-10-225000090233
3746cdb33-65cb-49db-8642-5bdda7b30de6 (view SPL)Bacitracin for Injection, USPprescriptionHuman PrescriptionPharmacia And Upjohn CompanyMANUFACTURE2012-08-242000090234
491c64e3b-83c8-4fce-87c3-7e035e65e270 (view SPL)Bacitracin for Injection, USPprescriptionHuman PrescriptionX-Gen Pharmaceuticals, Inc.2015-10-054398220278
5a3d2f60c-d3e8-4ce8-92eb-d3044783e5dd (view SPL)Bacitracin for Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2011-08-171633230329
6accddb51-2ca2-4b92-a028-b3d92124015c (view SPL)BACiiM To reduce the development of drug-resistant bacteria and maintain the effectiveness of bacitracin and other antibacterial drugs, bacitracin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.For Intramuscular UseprescriptionHuman PrescriptionX-Gen Pharmaceuticals, Inc.2013-01-2814398220277
7be306d60-553d-4b8c-8aad-539da646d8e9 (view SPL)Bacitracin for Injection, USPprescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, MANUFACTURE2014-09-0310000090233
8f706d901-25ab-4486-a64d-b362470baecd (view SPL)Bacitracin for Injection, USP For IM UseprescriptionHuman PrescriptionSagent Pharmaceuticals2009-07-086250210116

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