Dexamethasone / Neomycin / Polymyxin B Ophthalmic Ointment

Brand(s)
Maxitrol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Alcon Laboratories, Inc. (2011-08-16)
Oldest Current Product
1972-01-17
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
OPHTHALMIC OINTMENT\DEXAMETHASONE:NEOMYCIN:POLYMYXIN B
FDAOB
OPHTHALMIC\OINTMENT\DEXAMETHASONE: NEOMYCIN SULFATE: POLYMYXIN B SULFATE
SPL Active
OPHTHALMIC\OINTMENT\DEXAMETHASONE: NEOMYCIN SULFATE: POLYMYXIN B SULFATE
SPL Moiety
OPHTHALMIC\OINTMENT\DEXAMETHASONE: NEOMYCIN: POLYMYXIN B

product(s) by strength(s)

dexamethasone 0.001 mg/mg / neomycin 0.0035 mg/mg / polymyxin b 10 unt/mg ophthalmic ointment

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000650631MaxitrolNDAAlcon Laboratories, Inc.1972-01-17DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICOINTMENTNDA050065d17cecdb-c7cb-41cc-a11e-00c6ed0dcc11

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005744160ANDAPaddock Laboratories, Llc2014-07-03DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICOINTMENTANDA062938c8ae4afe-4f06-4441-9c5b-52f485f8f2f5
2009047938ANDAMajor1994-07-25DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICOINTMENTANDA06406396122457-2d6f-4206-9eb2-e68c98b83f6a
3116951436ANDAButler Animal Health Supply1994-07-25DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICOINTMENTANDA064063ca8900f2-cf16-425c-91f3-c41f8296358f
4139850014ANDAMwi1994-07-25DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICOINTMENTANDA0640638d55dfcf-788d-4504-aebd-afcc98c81345
5140490466ANDARxv1994-07-25DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICOINTMENTANDA0640636dc7154e-2173-4dd1-baf0-0f45af6f68c2
6242080795ANDABausch & Lomb Incorporated1994-07-25DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICOINTMENTANDA0640634456d10b-9995-4430-b692-a8859ea36deb
7481020003ANDAFera Pharmaceuticals2011-07-20DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICOINTMENTANDA0629380d8905a2-b910-474f-a212-599a8f72ac2c
8573190307ANDAClipper Distributing Company, Llc1994-07-25DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICOINTMENTANDA0640632a1d77e9-c706-4d9b-9745-e93ef4919c8a
9613140631NDA AUTHORIZED GENERICSandoz Inc1996-02-21DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICOINTMENTNDA0500657f2e3c46-9f39-45e7-99a9-64cc4f6f649d

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548681192ANDAPhysicians Total Care, Inc.2002-11-11DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICOINTMENT24208079535ANDA0640636370edde-52ca-409c-982c-3bf1d9e106bc
2687889373ANDAPreferred Pharmaceuticals, Inc.2014-09-02DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICOINTMENT005744160ANDA062938b12866e9-92ce-4c17-8b5d-fa755dd717ef
3687889384ANDAPreferred Pharmaceuticals, Inc.2015-05-11DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICOINTMENT481020003ANDA06293842da5857-e274-416d-bcd4-4ff33ea9eef0
4687889882NDA AUTHORIZED GENERICPreferred Pharmaceuticals, Inc.2012-04-02DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICOINTMENT613140631NDA0500658e467d61-e26f-410e-b582-465432f087c1

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA062411DEXASPORINTruePHARMAFAIR INC1983-05-16ANDA062411_001
2ANDA062566DEXACIDINTrueNOVARTIS PHARMACEUTICALS CORP1985-02-22ANDA062566_001
3ANDA062938NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEPERRIGO CO TENNESSEE INC1989-07-31ANDA062938_001
4ANDA064063NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEBAUSCH AND LOMB PHARMACEUTICALS INC1994-07-25ANDA064063_001
5NDA050065MAXITROLALCON LABORATORIES INCNDA050065_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA062411_001discontinuedPOLYMYXIN B SULFATE (10,000 UNITS/GM), DEXAMETHASONE (0.1%), NEOMYCIN SULFATE (EQ 3.5MG BASE/GM)OPHTHALMICOINTMENTFalse1983-05-16DEXASPORIN
2ANDA062566_001discontinuedNEOMYCIN SULFATE (EQ 3.5MG BASE/GM), DEXAMETHASONE (0.1%), POLYMYXIN B SULFATE (10,000 UNITS/GM)OPHTHALMICOINTMENTFalse1985-02-22DEXACIDIN
3ANDA062938_001RXDEXAMETHASONE (0.1%), NEOMYCIN SULFATE (EQ 3.5MG BASE/GM), POLYMYXIN B SULFATE (10,000 UNITS/GM)OPHTHALMICOINTMENTFalseAT1989-07-31NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
4ANDA064063_001RXPOLYMYXIN B SULFATE (10,000 UNITS/GM), DEXAMETHASONE (0.1%), NEOMYCIN SULFATE (EQ 3.5MG BASE/GM)OPHTHALMICOINTMENTFalseAT1994-07-25NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
5NDA050065_002RXPOLYMYXIN B SULFATE (10,000 UNITS/GM), NEOMYCIN SULFATE (EQ 3.5MG BASE/GM), DEXAMETHASONE (0.1%)OPHTHALMICOINTMENTTrueATMAXITROL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10d8905a2-b910-474f-a212-599a8f72ac2c (view SPL)NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OPHTHALMIC OINTMENT USPprescriptionHuman PrescriptionFera Pharmaceuticals2011-07-211481020003
22a1d77e9-c706-4d9b-9745-e93ef4919c8a (view SPL)Neomycin and Polymyxin BSulfates and DexamethasoneOphthalmic Ointment USPprescriptionHuman PrescriptionClipper Distributing Company, LlcMANUFACTURE2010-11-031573190307
342da5857-e274-416d-bcd4-4ff33ea9eef0 (view SPL)NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OPHTHALMIC OINTMENT USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2015-05-111687889384
44456d10b-9995-4430-b692-a8859ea36deb (view SPL)Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment USPprescriptionHuman PrescriptionBausch & Lomb IncorporatedAPI MANUFACTURE, MANUFACTURE2013-08-165242080795
56370edde-52ca-409c-982c-3bf1d9e106bc (view SPL)Neomycin and Polymyxin BSulfates and DexamethasoneOphthalmic Ointment USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-08-121548681192
66dc7154e-2173-4dd1-baf0-0f45af6f68c2 (view SPL)Neomycin and Polymyxin BSulfates and DexamethasoneOphthalmic Ointment USPprescriptionHuman PrescriptionRxvMANUFACTURE2010-11-031140490466
77f2e3c46-9f39-45e7-99a9-64cc4f6f649d (view SPL)Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic OintmentprescriptionHuman PrescriptionSandoz IncMANUFACTURE2011-07-201613140631
88d55dfcf-788d-4504-aebd-afcc98c81345 (view SPL)Neomycin and Polymyxin BSulfates and DexamethasoneOphthalmic Ointment USPprescriptionHuman PrescriptionMwiMANUFACTURE2010-11-031139850014
98e467d61-e26f-410e-b582-465432f087c1 (view SPL)Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic OintmentprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2012-04-021687889882
1096122457-2d6f-4206-9eb2-e68c98b83f6a (view SPL)Neomycin and Polymyxin BSulfates and DexamethasoneOphthalmic Ointment USPprescriptionHuman PrescriptionMajorMANUFACTURE2010-11-031009047938
11b12866e9-92ce-4c17-8b5d-fa755dd717ef (view SPL)Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment USP STERILE Rx OnlyprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2014-09-031687889373
12c8ae4afe-4f06-4441-9c5b-52f485f8f2f5 (view SPL)Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment USP STERILE Rx OnlyprescriptionHuman PrescriptionPaddock Laboratories, Llc2014-07-151005744160
13ca8900f2-cf16-425c-91f3-c41f8296358f (view SPL)Neomycin and Polymyxin BSulfates and DexamethasoneOphthalmic Ointment USPprescriptionHuman PrescriptionButler Animal Health SupplyMANUFACTURE2010-11-021116951436
14d17cecdb-c7cb-41cc-a11e-00c6ed0dcc11 (view SPL)Maxitrol (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) SterileprescriptionHuman PrescriptionAlcon Laboratories, Inc.MANUFACTURE2011-08-165000650631

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