Dexamethasone / Neomycin / Polymyxin B Ophthalmic Suspension

Brand(s)
Maxitrol, Methadex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Alcon Laboratories, Inc. (2011-08-16)
Oldest Current Product
1964-11-15
License(s)
NDA, ANDA
RxNORM
OPHTHALMIC SUSPENSION\DEXAMETHASONE:NEOMYCIN:POLYMYXIN B
FDAOB
OPHTHALMIC\SUSPENSION_DROPS\DEXAMETHASONE: NEOMYCIN SULFATE: POLYMYXIN B SULFATE
SPL Active
OPHTHALMIC\SOLUTION/DROPS\DEXAMETHASONE: NEOMYCIN SULFATE: POLYMYXIN B SULFATE
OPHTHALMIC\SUSPENSION/DROPS\DEXAMETHASONE: NEOMYCIN SULFATE: POLYMYXIN B SULFATE
OPHTHALMIC\SUSPENSION\DEXAMETHASONE: NEOMYCIN SULFATE: POLYMYXIN B SULFATE
SPL Moiety
OPHTHALMIC\SOLUTION/DROPS\DEXAMETHASONE: NEOMYCIN: POLYMYXIN B
OPHTHALMIC\SUSPENSION/DROPS\DEXAMETHASONE: NEOMYCIN: POLYMYXIN B
OPHTHALMIC\SUSPENSION\DEXAMETHASONE: NEOMYCIN: POLYMYXIN B

product(s) by strength(s)

dexamethasone 1 mg/ml / neomycin 3.5 mg/ml / polymyxin b 10000 unt/ml ophthalmic suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1009980630MaxitrolNDAAlcon Laboratories, Inc.1964-11-15DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSUSPENSIONNDA050023277ff310-b7dc-43b6-8a16-885b58882bc0

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1116951403ANDAButler Animal Health Supply1995-09-13DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSUSPENSION/DROPSANDA064135bf900a90-9ece-4bbb-9a72-6f7e5c04e202
2139850028ANDAMwi1995-09-13DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSUSPENSION/DROPSANDA06413501e58ae0-cdcf-4c1f-bfb9-9d0fc3ebd002
3140490830ANDARxv1995-09-13DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSUSPENSION/DROPSANDA06413516bb81d6-a9e3-47b0-9cc5-c41fe3ef86a6
4242080830ANDABausch & Lomb Incorporated1995-09-13DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSUSPENSION/DROPSANDA064135d6d78668-a978-4cd3-bbcd-1293b5044ec9
5573190347ANDAClipper Distributing Company, Llc1995-09-13DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSUSPENSION/DROPSANDA06413561b2cb3a-9512-48a0-a01d-2cacebeae7fe
6613140630ANDASandoz Inc1996-02-21DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSUSPENSIONANDA062341cf1a6da8-ba79-4bff-a13b-6effb67f6c1c

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950595ANDARebel Distributors Corp1986-11-17DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSUSPENSION613140630ANDA0627218060a686-f1e1-4171-9b99-28791e502bdb
2548681070ANDAPhysicians Total Care, Inc.2007-12-04DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSUSPENSION613140630ANDA062721556cffdd-5d80-486c-a3d4-af92effea298

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1009043003MethadexANDAMajor1995-09-13DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSOLUTION/DROPS009043003ANDA064135821874ba-a22b-4014-900e-f5edad634fc4
2165900167ANDAStat Rx Usa Llc1984-05-22DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSUSPENSION613140630ANDA0623414db25db3-0494-4b5d-a5e1-c55a12395bb2
3499990141ANDALake Erie Medical Dba Quality Care Products Llc1996-02-21DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSUSPENSION613140630ANDA062341f8dcbed7-2d36-4d49-b443-a6edd0fb69c3
4504360830ANDAUnit Dose Services1995-09-13DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSUSPENSION/DROPS242080830ANDA06413575f2c5ec-c575-4aaa-aa64-60a9263c018e
5529590085ANDAH.J. Harkins Company, Inc.1995-09-13DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSUSPENSION/DROPS242080830ANDA06413553c0710d-08e5-42ac-afb8-4faa13ae5833
6619190167ANDADirect Rx2015-01-01DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSUSPENSION/DROPS242080830ANDA064135e4df24bb-c4ed-497f-bf06-9cd6837ea90f
7631870498ANDAProficient Rx Lp1995-09-13DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSUSPENSION/DROPS242080830ANDA064135548089f3-29d8-4ba8-af21-9e04356ac29c
8687889120ANDAPreferred Pharmaceuticals, Inc.1996-02-21DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSUSPENSION613140630ANDA0623410f09bcda-5041-48f6-8107-2785875efd51
9687889702ANDAPreferred Pharmaceuticals, Inc.2013-03-14DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICSUSPENSION/DROPS242080830ANDA064135449a6fd8-c2ac-40d0-b74a-e5c7fc6670f3

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA062341MAXITROLALCON LABORATORIES INC1984-05-22ANDA062341_001
2ANDA062428DEXASPORINTruePHARMAFAIR INC1983-05-18ANDA062428_001
3ANDA062544DEXACIDINTrueNOVARTIS PHARMACEUTICALS CORP1984-10-29ANDA062544_001
4ANDA062721NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONETrueALCON PHARMACEUTICALS LTD1986-11-17ANDA062721_001
5ANDA064135DEXASPORINBAUSCH AND LOMB PHARMACEUTICALS INC1995-09-13ANDA064135_001
6NDA050023MAXITROLALCON LABORATORIES INCNDA050023_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA062341_001RXNEOMYCIN SULFATE (EQ 3.5MG BASE/ML), POLYMYXIN B SULFATE (10,000 UNITS/ML), DEXAMETHASONE (0.1%)OPHTHALMICSUSPENSION/DROPSFalseAT1984-05-22MAXITROL
2ANDA062428_001discontinuedNEOMYCIN SULFATE (EQ 3.5MG BASE/ML), DEXAMETHASONE (0.1%), POLYMYXIN B SULFATE (10,000 UNITS/ML)OPHTHALMICSUSPENSION/DROPSFalse1983-05-18DEXASPORIN
3ANDA062544_001discontinuedNEOMYCIN SULFATE (EQ 3.5MG BASE/ML), POLYMYXIN B SULFATE (10,000 UNITS/ML), DEXAMETHASONE (0.1%)OPHTHALMICSUSPENSION/DROPSFalse1984-10-29DEXACIDIN
4ANDA062721_001discontinuedPOLYMYXIN B SULFATE (10,000 UNITS/ML), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML), DEXAMETHASONE (0.1%)OPHTHALMICSUSPENSION/DROPSFalse1986-11-17NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
5ANDA064135_001RXDEXAMETHASONE (0.1%), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML), POLYMYXIN B SULFATE (10,000 UNITS/ML)OPHTHALMICSUSPENSION/DROPSFalseAT1995-09-13DEXASPORIN
6NDA050023_002RXNEOMYCIN SULFATE (EQ 3.5MG BASE/ML), POLYMYXIN B SULFATE (10,000 UNITS/ML), DEXAMETHASONE (0.1%)OPHTHALMICSUSPENSION/DROPSTrueATMAXITROL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
101e58ae0-cdcf-4c1f-bfb9-9d0fc3ebd002 (view SPL)Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension USP (Sterile)prescriptionHuman PrescriptionMwiMANUFACTURE2010-11-031139850028
20f09bcda-5041-48f6-8107-2785875efd51 (view SPL)Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension SterileprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2015-02-262687889120
316bb81d6-a9e3-47b0-9cc5-c41fe3ef86a6 (view SPL)Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension USP (Sterile)prescriptionHuman PrescriptionRxvMANUFACTURE2010-11-031140490830
4277ff310-b7dc-43b6-8a16-885b58882bc0 (view SPL)MAXITROL (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) SterileprescriptionHuman PrescriptionAlcon Laboratories, Inc.MANUFACTURE2011-08-163009980630
5449a6fd8-c2ac-40d0-b74a-e5c7fc6670f3 (view SPL)Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension USP (Sterile)prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2015-03-022687889702
64db25db3-0494-4b5d-a5e1-c55a12395bb2 (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2010-06-091165900167
753c0710d-08e5-42ac-afb8-4faa13ae5833 (view SPL)Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension USP (Sterile)prescriptionHuman PrescriptionH.J. Harkins Company, Inc.ANALYSIS, MANUFACTURE2012-01-193529590085
8548089f3-29d8-4ba8-af21-9e04356ac29c (view SPL)Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension USP (Sterile)prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870498
9556cffdd-5d80-486c-a3d4-af92effea298 (view SPL)Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension SterileprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-06-011548681070
1061b2cb3a-9512-48a0-a01d-2cacebeae7fe (view SPL)Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension USP (Sterile)prescriptionHuman PrescriptionClipper Distributing Company, LlcMANUFACTURE2010-11-031573190347
1175f2c5ec-c575-4aaa-aa64-60a9263c018e (view SPL)Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension USP (Sterile)prescriptionHuman PrescriptionUnit Dose ServicesREPACK2010-09-163504360830
128060a686-f1e1-4171-9b99-28791e502bdb (view SPL)Neomycin and Polymyxin B Sulfatesand Dexamethasone OphthalmicSuspensionSterileprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-10-081216950595
13821874ba-a22b-4014-900e-f5edad634fc4 (view SPL)Neomycin and Polymyxin B Sulfates and DexamethasoneprescriptionHuman PrescriptionMajor2009-09-011009043003
14bf900a90-9ece-4bbb-9a72-6f7e5c04e202 (view SPL)Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension USP (Sterile)prescriptionHuman PrescriptionButler Animal Health SupplyMANUFACTURE2010-11-031116951403
15cf1a6da8-ba79-4bff-a13b-6effb67f6c1c (view SPL)Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension SterileprescriptionHuman PrescriptionSandoz IncMANUFACTURE2011-08-163613140630
16d6d78668-a978-4cd3-bbcd-1293b5044ec9 (view SPL)Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension USP (Sterile)prescriptionHuman PrescriptionBausch & Lomb IncorporatedAPI MANUFACTURE, MANUFACTURE2013-10-174242080830
17e4df24bb-c4ed-497f-bf06-9cd6837ea90f (view SPL)NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONEprescriptionHuman PrescriptionDirect Rxrelabel, repack2015-08-114619190167
18f8dcbed7-2d36-4d49-b443-a6edd0fb69c3 (view SPL)Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension SterileprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel2012-06-143864499990141

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