Neomycin / Polymyxin B Irrigation Solution

Brand(s)
Neosporin G. U. Irrigant
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pfizer Laboratories Div Pfizer Inc (2015-05-18)
Oldest Current Product
1966-06-28
License(s)
ANDA
RxNORM
IRRIGATION SOLUTION\NEOMYCIN:POLYMYXIN B
FDAOB
IRRIGATION\SOLUTION\NEOMYCIN SULFATE: POLYMYXIN B SULFATE
SPL Active
IRRIGATION\IRRIGANT\NEOMYCIN SULFATE: POLYMYXIN B SULFATE
IRRIGATION\SOLUTION\NEOMYCIN SULFATE: POLYMYXIN B SULFATE
SPL Moiety
IRRIGATION\IRRIGANT\NEOMYCIN: POLYMYXIN B
IRRIGATION\SOLUTION\NEOMYCIN: POLYMYXIN B

product(s) by strength(s)

neomycin 40 mg/ml / polymyxin b 200000 unt/ml irrigation solution

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005912190ANDAWatson Laboratories, Inc.2010-10-25NEOMYCIN SULFATE, POLYMYXIN B SULFATEIRRIGATIONIRRIGANTANDA062664aa0212d9-3c11-420b-96d9-990194d435fa
2398221201ANDAX-Gen Pharmaceuticals, Inc.2006-01-19NEOMYCIN SULFATE, POLYMYXIN B SULFATEIRRIGATIONSOLUTIONANDA065106a2f47d77-efd3-4c84-a364-08fb6d9978eb
3398221220ANDAX-Gen Pharmaceuticals, Inc.2006-01-31NEOMYCIN SULFATE, POLYMYXIN B SULFATEIRRIGATIONSOLUTIONANDA065108a2f47d77-efd3-4c84-a364-08fb6d9978eb
4615700047Neosporin G. U. IrrigantANDAPfizer Laboratories Div Pfizer Inc1966-06-28NEOMYCIN SULFATE, POLYMYXIN B SULFATEIRRIGATIONSOLUTIONANDA0607071a9f81d8-277d-4f2c-39b0-412e01954f8a
5615700048Neosporin G. U. IrrigantANDAPfizer Laboratories Div Pfizer Inc1966-06-28NEOMYCIN SULFATE, POLYMYXIN B SULFATEIRRIGATIONSOLUTIONANDA0607071a9f81d8-277d-4f2c-39b0-412e01954f8a

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA060707NEOSPORIN G.U. IRRIGANTMONARCH PHARMACEUTICALS INCANDA060707_001
2ANDA062664NEOMYCIN AND POLYMYXIN B SULFATEWATSON LABORATORIES INC1986-04-08ANDA062664_001
3ANDA065106NEOMYCIN AND POLYMYXIN B SULFATEX GEN PHARMACEUTICALS INC2006-01-31ANDA065106_001
4ANDA065108NEOMYCIN AND POLYMYXIN B SULFATEX GEN PHARMACEUTICALS INC2006-01-31ANDA065108_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA060707_001RXNEOMYCIN SULFATE (EQ 40MG BASE/ML), POLYMYXIN B SULFATE (200,000 UNITS/ML)IRRIGATIONSOLUTIONTrueATNEOSPORIN G.U. IRRIGANT
2ANDA062664_001RXPOLYMYXIN B SULFATE (200,000 UNITS/ML), NEOMYCIN SULFATE (EQ 40MG BASE/ML)IRRIGATIONSOLUTIONFalseAT1986-04-08NEOMYCIN AND POLYMYXIN B SULFATE
3ANDA065106_001RXPOLYMYXIN B SULFATE (200,000 UNITS/ML), NEOMYCIN SULFATE (EQ 40MG BASE/ML)IRRIGATIONSOLUTIONFalseAT2006-01-31NEOMYCIN AND POLYMYXIN B SULFATE
4ANDA065108_001RXPOLYMYXIN B SULFATE (200,000 UNITS/ML), NEOMYCIN SULFATE (EQ 40MG BASE/ML)IRRIGATIONSOLUTIONFalseAT2006-01-31NEOMYCIN AND POLYMYXIN B SULFATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11a9f81d8-277d-4f2c-39b0-412e01954f8a (view SPL)NEOSPORIN G.U. Irrigant Sterile(neomycin sulfatepolymyxin B sulfate solution for irrigation)prescriptionHuman PrescriptionPfizer Laboratories Div Pfizer IncANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-05-185615700047, 615700048
2a2f47d77-efd3-4c84-a364-08fb6d9978eb (view SPL)Neomycin and Polymyxin B Sulfates Solution for Irrigation, USP Rx OnlyprescriptionHuman PrescriptionX-Gen Pharmaceuticals, Inc.ANALYSIS, MANUFACTURE2012-05-106398221201, 398221220
3aa0212d9-3c11-420b-96d9-990194d435fa (view SPL)NEOMYCIN AND POLYMYXIN B SULFATESSOLUTION FOR IRRIGATION USPNOT FOR INJECTIONRx onlyprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2012-08-209005912190

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