Hydrocortisone / Neomycin / Polymyxin B Ophthalmic Suspension

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sandoz Inc (2011-08-19)
Oldest Current Product
1983-08-25
License(s)
ANDA
RxNORM
OPHTHALMIC SUSPENSION\HYDROCORTISONE:NEOMYCIN:POLYMYXIN B
FDAOB
OPHTHALMIC\SUSPENSION_DROPS\HYDROCORTISONE: NEOMYCIN SULFATE: POLYMYXIN B SULFATE
OTIC\SOLUTION/DROPS\HYDROCORTISONE: NEOMYCIN SULFATE: POLYMYXIN B SULFATE\rdfq
SPL Active
OPHTHALMIC\SUSPENSION\HYDROCORTISONE: NEOMYCIN SULFATE: POLYMYXIN B SULFATE
SPL Moiety
OPHTHALMIC\SUSPENSION\HYDROCORTISONE: NEOMYCIN: POLYMYXIN B

product(s) by strength(s)

hydrocortisone 10 mg/ml / neomycin 3.5 mg/ml / polymyxin b 10000 unt/ml ophthalmic suspension

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1613140641ANDASandoz Inc2003-05-09HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSUSPENSIONANDA06287496a7b0a5-030a-42dc-80cd-35c4e9aa1b6d

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900347ANDAStat Rx Usa Llc1983-08-25HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSUSPENSION613140641ANDA06242364e4cb91-f5bd-4a2f-b92d-0a1341f40d35
2548683250ANDAPhysicians Total Care, Inc.1994-04-07HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSUSPENSION61314064175ANDA062423b5b31564-0bf8-43ef-8612-faa7093f1ab5

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA060730OTOCORTTrueWATSON LABORATORIES INCANDA060730_002Hydrocortisone / Neomycin / Polymyxin B Otic Solution
Hydrocortisone / Neomycin / Polymyxin B Otic Suspension
2ANDA062394NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONETruePHARMAFAIR INC1982-09-29ANDA062394_001Hydrocortisone / Neomycin / Polymyxin B Otic Solution
Hydrocortisone / Neomycin / Polymyxin B Otic Suspension
3ANDA062423NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONEALCON PHARMACEUTICALS LTD1983-08-25ANDA062423_001Hydrocortisone / Neomycin / Polymyxin B Otic Solution
Hydrocortisone / Neomycin / Polymyxin B Otic Suspension
4ANDA062623NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONETruePHARMAFAIR INC1985-09-24ANDA062623_001
5ANDA062874NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONEALCON PHARMACEUTICALS LTD1988-05-11ANDA062874_001
6ANDA064053NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONEBAUSCH AND LOMB PHARMACEUTICALS INC1995-12-29ANDA064053_001Hydrocortisone / Neomycin / Polymyxin B Otic Solution
Hydrocortisone / Neomycin / Polymyxin B Otic Suspension
7ANDA065216NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONELUITPOLD PHARMACEUTICALS INC2005-10-31ANDA065216_001Hydrocortisone / Neomycin / Polymyxin B Otic Solution
Hydrocortisone / Neomycin / Polymyxin B Otic Suspension
8NDA050169CORTISPORINTrueMONARCH PHARMACEUTICALS INCNDA050169_001
9NDA050479CORTISPORINMONARCH PHARMACEUTICALS INCNDA050479_001Hydrocortisone / Neomycin / Polymyxin B Otic Solution
Hydrocortisone / Neomycin / Polymyxin B Otic Suspension

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA060730_002discontinuedPOLYMYXIN B SULFATE (10,000 UNITS/ML), HYDROCORTISONE (1%), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML)SOLUTION/DROPSFalseOTOCORT
2ANDA062394_001discontinuedHYDROCORTISONE (1%), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML), POLYMYXIN B SULFATE (10,000 UNITS/ML)SOLUTION/DROPSFalse1982-09-29NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE
3ANDA062423_001RXNEOMYCIN SULFATE (EQ 3.5MG BASE/ML), POLYMYXIN B SULFATE (10,000 UNITS/ML), HYDROCORTISONE (1%)SOLUTION/DROPSFalseAT1983-08-25NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
4ANDA062623_001discontinuedPOLYMYXIN B SULFATE (10,000 UNITS/ML), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML), HYDROCORTISONE (1%)OPHTHALMICSUSPENSION/DROPSFalse1985-09-24NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE
5ANDA062874_001RXHYDROCORTISONE (1%), POLYMYXIN B SULFATE (10,000 UNITS/ML), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML)OPHTHALMICSUSPENSION/DROPSTrue1988-05-11NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
6ANDA064053_001RXNEOMYCIN SULFATE (EQ 3.5MG BASE/ML), HYDROCORTISONE (1%), POLYMYXIN B SULFATE (10,000 UNITS/ML)SOLUTION/DROPSFalseAT1995-12-29NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
7ANDA065216_001RXPOLYMYXIN B SULFATE (10,000 UNITS/ML), HYDROCORTISONE (1%), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML)SOLUTION/DROPSFalseAT2005-10-31NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
8NDA050169_001discontinuedNEOMYCIN SULFATE (EQ 3.5MG BASE/ML), HYDROCORTISONE (1%), POLYMYXIN B SULFATE (10,000 UNITS/ML)OPHTHALMICSUSPENSION/DROPSFalseCORTISPORIN
9NDA050479_001RXPOLYMYXIN B SULFATE (10,000 UNITS/ML), HYDROCORTISONE (1%), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML)SOLUTION/DROPSTrueATCORTISPORIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
164e4cb91-f5bd-4a2f-b92d-0a1341f40d35 (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llc2010-06-091165900347
296a7b0a5-030a-42dc-80cd-35c4e9aa1b6d (view SPL)NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OPHTHALMIC SUSPENSION, USPprescriptionHuman PrescriptionSandoz IncMANUFACTURE2011-08-194613140641
3b5b31564-0bf8-43ef-8612-faa7093f1ab5 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2011-04-271548683250

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