Ciprofloxacin / Hydrocortisone Otic Suspension

Brand(s)
Cipro HC
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Alcon Laboratories, Inc. (2011-08-12)
Oldest Current Product
1998-02-10
License(s)
NDA
RxNORM
OTIC SUSPENSION\CIPROFLOXACIN:HYDROCORTISONE
FDAOB
OTIC\SUSPENSION/DROPS\CIPROFLOXACIN HYDROCHLORIDE: HYDROCORTISONE\rdfq
SPL Active
AURICULAR (OTIC)\SUSPENSION\BENZYL ALCOHOL: CIPROFLOXACIN HYDROCHLORIDE: HYDROCORTISONE
AURICULAR (OTIC)\SUSPENSION\CIPROFLOXACIN HYDROCHLORIDE: HYDROCORTISONE
SPL Moiety
AURICULAR (OTIC)\SUSPENSION\BENZYL ALCOHOL: CIPROFLOXACIN: HYDROCORTISONE
AURICULAR (OTIC)\SUSPENSION\CIPROFLOXACIN: HYDROCORTISONE

product(s) by strength(s)

ciprofloxacin 2 mg/ml / hydrocortisone 10 mg/ml otic suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000658531Cipro HCNDAAlcon Laboratories, Inc.1999-03-15CIPROFLOXACIN HYDROCHLORIDE, HYDROCORTISONEAURICULAR (OTIC)SUSPENSIONNDA02080570b19501-34b6-4f95-a8dd-dd3e67d22399

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900053Cipro HCNDAStat Rx Usa Llc1998-02-10BENZYL ALCOHOL, CIPROFLOXACIN HYDROCHLORIDE, HYDROCORTISONEAURICULAR (OTIC)SUSPENSION000658531NDA020805598288ca-256a-4b9e-91e0-829f02cb8cd3
2548684365Cipro HCNDAPhysicians Total Care, Inc.2009-02-12BENZYL ALCOHOL, CIPROFLOXACIN HYDROCHLORIDE, HYDROCORTISONEAURICULAR (OTIC)SUSPENSION000658531NDA02080514b45f78-0bc0-4e25-831e-d2a0006b2b87

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA020805CIPRO HCALCON PHARMACEUTICALS LTD1998-02-10p5843930, METHOD OF TREATING OTITIS
p5965549, SUBSTANCE
NDA020805_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA020805_001RXHYDROCORTISONE (1%), CIPROFLOXACIN HYDROCHLORIDE (EQ 0.2% BASE)SUSPENSION/DROPSTrue1998-02-10CIPRO HC

patent(s)

#idexpiration dateapplication(s)
1p5843930 (view patent)2015-06-06NDA020805
2p5965549 (view patent)2015-06-06NDA020805

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
114b45f78-0bc0-4e25-831e-d2a0006b2b87 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-12-131548684365
2598288ca-256a-4b9e-91e0-829f02cb8cd3 (view SPL)Cipro (ciprofloxacin hydrochloride, hydrocortisone and benzyl alcohol) SuspensionprescriptionHuman PrescriptionStat Rx Usa Llc2009-10-271165900053
370b19501-34b6-4f95-a8dd-dd3e67d22399 (view SPL)CIPRO HC OTIC (ciprofloxacin hydrochloride and hydrocortisone otic suspension)prescriptionHuman PrescriptionAlcon Laboratories, Inc.MANUFACTURE2011-08-126000658531

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