Bacitracin / Hydrocortisone / Neomycin / Polymyxin B Topical Ointment

Brand(s)
Cortisporin Ointment
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pfizer Laboratories Div Pfizer Inc (2015-04-01)
Oldest Current Product
1955-04-15
License(s)
NDA
RxNORM
TOPICAL OINTMENT\BACITRACIN:HYDROCORTISONE:NEOMYCIN:POLYMYXIN B
FDAOB
TOPICAL\OINTMENT\BACITRACIN ZINC: HYDROCORTISONE: NEOMYCIN SULFATE: POLYMYXIN B SULFATE
SPL Active
TOPICAL\OINTMENT\BACITRACIN ZINC: HYDROCORTISONE: NEOMYCIN SULFATE: POLYMYXIN B SULFATE
SPL Moiety
TOPICAL\OINTMENT\BACITRACIN: HYDROCORTISONE: NEOMYCIN: POLYMYXIN B

product(s) by strength(s)

bacitracin 0.4 unt/mg / hydrocortisone 0.01 mg/mg / neomycin 0.0035 mg/mg / polymyxin b 5 unt/mg topical ointment

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1615700031Cortisporin OintmentNDAPfizer Laboratories Div Pfizer Inc1955-04-15BACITRACIN ZINC, HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATETOPICALOINTMENTNDA050168097a7a8d-04d4-4736-c8b7-0796117457bf

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA062381NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONETruePHARMAFAIR INC1985-09-06ANDA062381_001
2NDA050168CORTISPORINMONARCH PHARMACEUTICALS INC1984-05-04NDA050168_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA062381_001discontinuedNEOMYCIN SULFATE (EQ 3.5MG BASE/GM), POLYMYXIN B SULFATE (5,000 UNITS/GM), BACITRACIN ZINC (400 UNITS/GM), HYDROCORTISONE (1%)TOPICALOINTMENTFalse1985-09-06NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE
2NDA050168_002RXBACITRACIN ZINC (400 UNITS/GM), NEOMYCIN SULFATE (EQ 3.5MG BASE/GM), POLYMYXIN B SULFATE (5,000 UNITS/GM), HYDROCORTISONE (1%)TOPICALOINTMENTTrue1984-05-04CORTISPORIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1097a7a8d-04d4-4736-c8b7-0796117457bf (view SPL)CORTISPORIN Ointment(neomycin and polymyxin B sulfates, bacitracin zinc, and hydrocortisone ointment, USP)prescriptionHuman PrescriptionPfizer Laboratories Div Pfizer IncANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-04-016615700031

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