Gramicidin / Neomycin / Polymyxin B Ophthalmic Solution

Brand(s)
Neocidin Solution, Neosporin Solution
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bausch & Lomb Incorporated (2013-08-12)
Oldest Current Product
1955-04-11
License(s)
ANDA
RxNORM
OPHTHALMIC SOLUTION\GRAMICIDIN:NEOMYCIN:POLYMYXIN B
FDAOB
OPHTHALMIC\SOLUTION_DROPS\GRAMICIDIN: NEOMYCIN SULFATE: POLYMYXIN B SULFATE
SPL Active
OPHTHALMIC\SOLUTION/DROPS\GRAMICIDIN: NEOMYCIN SULFATE: POLYMYXIN B SULFATE
OPHTHALMIC\SOLUTION\GRAMICIDIN: NEOMYCIN SULFATE: POLYMYXIN B SULFATE
SPL Moiety
OPHTHALMIC\SOLUTION/DROPS\GRAMICIDIN: NEOMYCIN: POLYMYXIN B
OPHTHALMIC\SOLUTION\GRAMICIDIN: NEOMYCIN: POLYMYXIN B

product(s) by strength(s)

gramicidin 0.025 mg/ml / neomycin 1.75 mg/ml / polymyxin b 10000 unt/ml ophthalmic solution

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1242080790ANDABausch & Lomb Incorporated1996-01-31GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSOLUTION/DROPSANDA064047e6f8d2f6-adff-4ae1-982c-45562f0a8e28
2615700045Neosporin SolutionANDAPfizer Laboratories Div Pfizer Inc1955-04-11GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSOLUTIONANDA06058233e9b6d3-2b2b-4036-dd89-47177e23fcfe

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1009043016Neocidin SolutionANDAMajor2004-06-07GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSOLUTION/DROPS009043016ANDA064047b7aa0bae-255b-4792-a963-6606370a175f
2216950528ANDARebel Distributors Corp1996-01-31GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSOLUTION/DROPS242080790ANDA06404765edc059-0806-4625-b583-0e36f04cf085
3545691188ANDAA-S Medication Solutions Llc1996-01-31GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSOLUTION/DROPS242080790ANDA064047918a8b04-a656-4813-8b4e-6c4f3f208ee0
4548686253ANDAPhysicians Total Care, Inc.2011-04-26GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSOLUTION/DROPS242080790ANDA064047e2d2199c-3b8a-4071-9c01-d1e8879f9bff
5550451194ANDADispensing Solutions, Inc.1996-01-31GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSOLUTION/DROPS242080790ANDA06404794e3b620-f9b2-4c8b-9ee8-8b27207a2cab

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA060427NEO-POLYCINTrueDOW PHARMACEUTICAL CORP SUB DOW CHEMICAL COANDA060427_001
2ANDA060582NEOSPORINMONARCH PHARMACEUTICALS INCANDA060582_001
3ANDA062383NEOMYCIN SULFATE AND POLYMYXIN B SULFATE GRAMICIDINTruePHARMAFAIR INC1982-08-31ANDA062383_001
4ANDA062788NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDINTrueWATSON LABORATORIES INC1987-06-11ANDA062788_001
5ANDA062818NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDINTrueIPHARM DIV LYPHOMED INC1988-10-11ANDA062818_001
6ANDA064047NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDINBAUSCH AND LOMB PHARMACEUTICALS INC1996-01-31ANDA064047_001
7ANDA065187NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDINLUITPOLD PHARMACEUTICALS INC2005-10-28ANDA065187_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA060427_001discontinuedPOLYMYXIN B SULFATE (10,000 UNITS/ML), GRAMICIDIN (0.025MG/ML), NEOMYCIN SULFATE (EQ 1.75MG BASE/ML)OPHTHALMICSOLUTION/DROPSFalseNEO-POLYCIN
2ANDA060582_001RXPOLYMYXIN B SULFATE (10,000 UNITS/ML), GRAMICIDIN (0.025MG/ML), NEOMYCIN SULFATE (EQ 1.75MG BASE/ML)OPHTHALMICSOLUTION/DROPSTrueATNEOSPORIN
3ANDA062383_001discontinuedNEOMYCIN SULFATE (EQ 1.75MG BASE/ML), GRAMICIDIN (0.025MG/ML), POLYMYXIN B SULFATE (10,000 UNITS/ML)OPHTHALMICSOLUTION/DROPSFalse1982-08-31NEOMYCIN SULFATE AND POLYMYXIN B SULFATE GRAMICIDIN
4ANDA062788_001discontinuedPOLYMYXIN B SULFATE (10,000 UNITS/ML), NEOMYCIN SULFATE (EQ 1.75MG BASE/ML), GRAMICIDIN (0.025MG/ML)OPHTHALMICSOLUTION/DROPSFalse1987-06-11NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN
5ANDA062818_001discontinuedGRAMICIDIN (0.025MG/ML), POLYMYXIN B SULFATE (10,000 UNITS/ML), NEOMYCIN SULFATE (EQ 1.75MG BASE/ML)OPHTHALMICSOLUTION/DROPSFalse1988-10-11NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN
6ANDA064047_001RXPOLYMYXIN B SULFATE (10,000 UNITS/ML), NEOMYCIN SULFATE (EQ 1.75MG BASE/ML), GRAMICIDIN (0.025MG/ML)OPHTHALMICSOLUTION/DROPSTrueAT1996-01-31NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN
7ANDA065187_001RXGRAMICIDIN (0.025MG/ML), POLYMYXIN B SULFATE (10,000 UNITS/ML), NEOMYCIN SULFATE (EQ 1.75MG BASE/ML)OPHTHALMICSOLUTION/DROPSFalseAT2005-10-28NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
133e9b6d3-2b2b-4036-dd89-47177e23fcfe (view SPL)NEOSPORIN Ophthalmic Solution Sterile(neomycin and polymyxin B sulfates and gramicidin ophthalmic solution, USP)prescriptionHuman PrescriptionPfizer Laboratories Div Pfizer Inc2011-07-192615700045
265edc059-0806-4625-b583-0e36f04cf085 (view SPL)Neomycin and Polymyxin B Sulfatesand Gramicidin Ophthalmic Solution USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-01-031216950528
3918a8b04-a656-4813-8b4e-6c4f3f208ee0 (view SPL)Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP (Sterile)prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-291545691188
494e3b620-f9b2-4c8b-9ee8-8b27207a2cab (view SPL)Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP (Sterile)prescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2011-11-093550451194
5b7aa0bae-255b-4792-a963-6606370a175f (view SPL)Neomycin and Polymyxin B Sulfatesand GramicidinprescriptionHuman PrescriptionMajor2009-10-221009043016
6e2d2199c-3b8a-4071-9c01-d1e8879f9bff (view SPL)Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP (Sterile)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2011-03-091548686253
7e6f8d2f6-adff-4ae1-982c-45562f0a8e28 (view SPL)Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP (Sterile)prescriptionHuman PrescriptionBausch & Lomb IncorporatedAPI MANUFACTURE, MANUFACTURE2013-08-127242080790

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