Colistin / Hydrocortisone / Neomycin / THONZONIUM Otic Suspension

Brand(s)
Coly Mycin S, Cortisporin-TC
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Par Pharmaceutical Inc. (2010-01-29)
Oldest Current Product
2007-05-07
License(s)
NDA
RxNORM
OTIC SUSPENSION\COLISTIN:HYDROCORTISONE:NEOMYCIN:THONZONIUM
FDAOB
OTIC\SUSPENSION/DROPS\COLISTIN SULFATE: HYDROCORTISONE ACETATE: NEOMYCIN SULFATE: THONZONIUM BROMIDE\rdfq
SPL Active
AURICULAR (OTIC)\SUSPENSION\COLISTIN SULFATE: HYDROCORTISONE ACETATE: NEOMYCIN SULFATE: THONZONIUM BROMIDE
SPL Moiety
AURICULAR (OTIC)\SUSPENSION\COLISTIN: HYDROCORTISONE: NEOMYCIN: THONZONIUM BROMIDE

product(s) by strength(s)

colistin 3 mg/ml / hydrocortisone 10 mg/ml / neomycin 3.3 mg/ml / thonzonium bromide 0.5 mg/ml otic suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1420230108Coly Mycin SNDAPar Pharmaceutical Inc.2007-11-01COLISTIN SULFATE, HYDROCORTISONE ACETATE, NEOMYCIN SULFATE, THONZONIUM BROMIDEAURICULAR (OTIC)SUSPENSIONNDA050356317cc880-73fe-4561-897e-41489108b3ba

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548680564Cortisporin-TCNDAPhysicians Total Care, Inc.2007-05-07COLISTIN SULFATE, HYDROCORTISONE ACETATE, NEOMYCIN SULFATE, THONZONIUM BROMIDEAURICULAR (OTIC)SUSPENSION42023010901NDA0503560869fd8d-6dd7-4dc2-b33c-20d72dc47718

application(s)

#idtitleapplicantapproved drug
1NDA050356COLY-MYCIN SPAR STERILE PRODUCTS LLCNDA050356_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapplication
1NDA050356_001RXNEOMYCIN SULFATE (EQ 3.3MG BASE/ML), HYDROCORTISONE ACETATE (10MG/ML), THONZONIUM BROMIDE (0.5MG/ML), COLISTIN SULFATE (EQ 3MG BASE/ML)SUSPENSION/DROPSTrueCOLY-MYCIN S

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10869fd8d-6dd7-4dc2-b33c-20d72dc47718 (view SPL)Cortisporin-TC Otic Suspension with Neomycin and Hydrocortisone (colistin sulfateneomycin sulfatethonzonium bromidehydrocortisone acetate otic suspension)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-01-291548680564
2317cc880-73fe-4561-897e-41489108b3ba (view SPL)Coly-MycinS Otic with Neomycin and Hydrocortisone (colistin sulfateneomycin sulfatethonzonium bromidehydrocortisone acetate otic suspension)prescriptionHuman PrescriptionPar Pharmaceutical Inc.2010-01-294420230108
3dbcf5b03-6764-4fac-a382-e8c56bec2c16 (view SPL)Cortisporin-TC Otic Suspension with Neomycin and Hydrocortisone (colistin sulfateneomycin sulfatethonzonium bromidehydrocortisone acetate otic suspension)prescriptionHuman PrescriptionPar Pharmaceutical Inc.2015-06-164420230109

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