Hydrocortisone / Neomycin / Polymyxin B Otic Suspension

Brand(s)
Cortomycin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bausch & Lomb Incorporated (2013-09-20)
Oldest Current Product
1995-12-29
License(s)
ANDA
RxNORM
OTIC SUSPENSION\HYDROCORTISONE:NEOMYCIN:POLYMYXIN B
FDAOB
OTIC\SOLUTION/DROPS\HYDROCORTISONE: NEOMYCIN SULFATE: POLYMYXIN B SULFATE\rdfq
OTIC\SUSPENSION/DROPS\HYDROCORTISONE: NEOMYCIN SULFATE: POLYMYXIN B SULFATE\rdfq
SPL Active
AURICULAR (OTIC)\SUSPENSION/DROPS\HYDROCORTISONE: NEOMYCIN SULFATE: POLYMYXIN B SULFATE
AURICULAR (OTIC)\SUSPENSION\HYDROCORTISONE: NEOMYCIN SULFATE: POLYMYXIN B SULFATE
SPL Moiety
AURICULAR (OTIC)\SUSPENSION/DROPS\HYDROCORTISONE: NEOMYCIN: POLYMYXIN B
AURICULAR (OTIC)\SUSPENSION\HYDROCORTISONE: NEOMYCIN: POLYMYXIN B

product(s) by strength(s)

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

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1242080635ANDABausch & Lomb Incorporated1996-08-28HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAURICULAR (OTIC)SUSPENSION/DROPSANDA064065b0ee85dd-5fe1-46a3-9bff-606e489d20b1
2613140645ANDASandoz Inc2003-03-17HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAURICULAR (OTIC)SUSPENSIONANDA06248899d9030f-9118-412c-a377-d1df1c8fa723

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1009043017CortomycinANDAMajor1996-08-28HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAURICULAR (OTIC)SUSPENSION/DROPS009043017ANDA06406541cfa382-d4ae-43c5-83a5-1ecc635d109b
2216950438ANDARebel Distributors Corp1995-12-29HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAURICULAR (OTIC)SUSPENSION/DROPS242080635ANDA064053595ee3ac-2f33-4459-87ff-be002928059c
3521250271ANDARemedyrepack Inc.2013-06-13, 2013-11-22HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAURICULAR (OTIC)SUSPENSION613140645ANDA06248894fa2258-577a-4097-9224-7b1df1885ccc, c03c099d-dd34-4731-8f50-ec5c7126f7de
4521250602ANDARemedyrepack Inc.2013-06-06, 2013-11-22HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAURICULAR (OTIC)SUSPENSION/DROPS242080635ANDA06406568d07fc1-a8ab-4b49-96c2-706b91ba82e0, aa6d6ba9-73af-4918-ac3c-0a2c1078f605
5521250746ANDARemedyrepack Inc.2013-10-15HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAURICULAR (OTIC)SUSPENSION/DROPS242080635ANDA0640656dda5239-b0be-42e5-860e-cd58406d50cb
6529590084ANDAH.J. Harkins Company, Inc.1996-08-28HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAURICULAR (OTIC)SUSPENSION/DROPS242080635ANDA06406502b16b3c-5276-4c5c-affa-9e08d99667b0
7545693259ANDAA-S Medication Solutions Llc1996-08-28HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAURICULAR (OTIC)SUSPENSION/DROPS242080635ANDA064065761d7ce5-8730-429f-a3bf-ff3092ca0fae
8581189931ANDAClinical Solutions Wholesale1996-08-28HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAURICULAR (OTIC)SUSPENSION/DROPS242080635ANDA0640655cc96e4f-81d1-4ce0-a6ea-c201f39f71c2
9617860131ANDARemedyrepack Inc.2015-01-07HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAURICULAR (OTIC)SUSPENSION613140645ANDA0624888bfc882e-ce38-4b27-846c-da47077bfba0
10619190662ANDADirect Rx2014-01-01HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAURICULAR (OTIC)SUSPENSION/DROPS242080635ANDA064065cb105db7-ab14-4b10-8a19-58bcb5eb27cd
11687889415ANDAPreferred Pharmaceuticals, Inc.2014-05-13HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAURICULAR (OTIC)SUSPENSION613140645ANDA06248885f47a6f-bd76-4369-bcb4-e70281a0ec28
12687889924ANDAPreferred Pharmaceuticals, Inc.2012-01-18HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAURICULAR (OTIC)SUSPENSION/DROPS242080635ANDA064065f8dc2b6f-daf3-4a3a-b31f-b97e2f152eae

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA060730OTOCORTTrueWATSON LABORATORIES INCANDA060730_002Hydrocortisone / Neomycin / Polymyxin B Otic Solution
Hydrocortisone / Neomycin / Polymyxin B Ophthalmic Suspension
2ANDA061816OTOBIONETrueSCHERING CORP SUB SCHERING PLOUGH CORPANDA061816_001
3ANDA062394NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONETruePHARMAFAIR INC1982-09-29ANDA062394_001Hydrocortisone / Neomycin / Polymyxin B Otic Solution
Hydrocortisone / Neomycin / Polymyxin B Ophthalmic Suspension
4ANDA062399OTICAIRTruePHARMAFAIR INC1982-11-18ANDA062399_001
5ANDA062423NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONEALCON PHARMACEUTICALS LTD1983-08-25ANDA062423_001Hydrocortisone / Neomycin / Polymyxin B Otic Solution
Hydrocortisone / Neomycin / Polymyxin B Ophthalmic Suspension
6ANDA062488NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONEALCON PHARMACEUTICALS LTD1985-11-06ANDA062488_001
7ANDA062521OTOCORTTrueACTAVIS LABORATORIES FL INC1985-07-11ANDA062521_001
8ANDA062617NEOMYCIN SULFATE, POLYMYXIN B SULFATE & HYDROCORTISONETruePHARMAFAIR INC1985-09-18ANDA062617_001
9ANDA062822PEDIOTICMONARCH PHARMACEUTICALS INC1987-09-29ANDA062822_001
10ANDA064053NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONEBAUSCH AND LOMB PHARMACEUTICALS INC1995-12-29ANDA064053_001Hydrocortisone / Neomycin / Polymyxin B Otic Solution
Hydrocortisone / Neomycin / Polymyxin B Ophthalmic Suspension
11ANDA064065OTICAIRBAUSCH AND LOMB PHARMACEUTICALS INC1996-08-28ANDA064065_001
12ANDA065216NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONELUITPOLD PHARMACEUTICALS INC2005-10-31ANDA065216_001Hydrocortisone / Neomycin / Polymyxin B Otic Solution
Hydrocortisone / Neomycin / Polymyxin B Ophthalmic Suspension
13ANDA065219NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONELUITPOLD PHARMACEUTICALS INC2006-05-01ANDA065219_001
14NDA050479CORTISPORINMONARCH PHARMACEUTICALS INCNDA050479_001Hydrocortisone / Neomycin / Polymyxin B Otic Solution
Hydrocortisone / Neomycin / Polymyxin B Ophthalmic Suspension
15NDA060613CORTISPORINCITRON PHARMA LLCNDA060613_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA060730_002discontinuedPOLYMYXIN B SULFATE (10,000 UNITS/ML), HYDROCORTISONE (1%), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML)SOLUTION/DROPSFalseOTOCORT
2ANDA061816_001discontinuedPOLYMYXIN B SULFATE (10,000 UNITS/ML), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML), HYDROCORTISONE (1%)SUSPENSION/DROPSFalseOTOBIONE
3ANDA062394_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
4ANDA062399_001discontinuedNEOMYCIN SULFATE (EQ 3.5MG BASE/ML), HYDROCORTISONE (1%), POLYMYXIN B SULFATE (10,000 UNITS/ML)SUSPENSION/DROPSFalse1982-11-18OTICAIR
5ANDA062423_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
6ANDA062488_001RXPOLYMYXIN B SULFATE (10,000 UNITS/ML), HYDROCORTISONE (1%), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML)SUSPENSION/DROPSFalseAT1985-11-06NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
7ANDA062521_001discontinuedNEOMYCIN SULFATE (EQ 3.5MG BASE/ML), HYDROCORTISONE (1%), POLYMYXIN B SULFATE (10,000 UNITS/ML)SUSPENSION/DROPSFalse1985-07-11OTOCORT
8ANDA062617_001discontinuedHYDROCORTISONE (1%), POLYMYXIN B SULFATE (10,000 UNITS/ML), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML)SUSPENSION/DROPSFalse1985-09-18NEOMYCIN SULFATE, POLYMYXIN B SULFATE & HYDROCORTISONE
9ANDA062822_001RXPOLYMYXIN B SULFATE (10,000 UNITS/ML), HYDROCORTISONE (1%), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML)SUSPENSION/DROPSFalseAT1987-09-29PEDIOTIC
10ANDA064053_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
11ANDA064065_001RXHYDROCORTISONE (1%), POLYMYXIN B SULFATE (10,000 UNITS/ML), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML)SUSPENSION/DROPSFalseAT1996-08-28OTICAIR
12ANDA065216_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
13ANDA065219_001RXPOLYMYXIN B SULFATE (10,000 UNITS/ML), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML), HYDROCORTISONE (1%)SUSPENSION/DROPSFalseAT2006-05-01NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
14NDA050479_001RXPOLYMYXIN B SULFATE (10,000 UNITS/ML), HYDROCORTISONE (1%), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML)SOLUTION/DROPSTrueATCORTISPORIN
15NDA060613_001RXPOLYMYXIN B SULFATE (10,000 UNITS/ML), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML), HYDROCORTISONE (1%)SUSPENSION/DROPSTrueATCORTISPORIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
102b16b3c-5276-4c5c-affa-9e08d99667b0 (view SPL)Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension USP (Sterile)prescriptionHuman PrescriptionH.J. Harkins Company, Inc.relabel, repack2012-04-205529590084
241cfa382-d4ae-43c5-83a5-1ecc635d109b (view SPL)Neomycin and Polymyxin B Sulfates and HydrocortisoneprescriptionHuman PrescriptionMajor2009-08-311009043017
3595ee3ac-2f33-4459-87ff-be002928059c (view SPL)Neomycin and Polymyxin B Sulfatesand Hydrocortisone Otic Suspension USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-10-081216950438
45cc96e4f-81d1-4ce0-a6ea-c201f39f71c2 (view SPL)Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension USP (Sterile)prescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL2013-11-181581189931
568d07fc1-a8ab-4b49-96c2-706b91ba82e0 (view SPL)Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension USP (Sterile)prescriptionHuman PrescriptionRemedyrepack Inc.2013-06-061521250602
66dda5239-b0be-42e5-860e-cd58406d50cb (view SPL)Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension USP (Sterile)prescriptionHuman PrescriptionRemedyrepack Inc.2013-10-151521250746
7761d7ce5-8730-429f-a3bf-ff3092ca0fae (view SPL)Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension USP (Sterile)prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-10-261545693259
885f47a6f-bd76-4369-bcb4-e70281a0ec28 (view SPL)Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Suspension, USP SterileprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2015-11-102687889415
98bfc882e-ce38-4b27-846c-da47077bfba0 (view SPL)Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Suspension, USPSterileprescriptionHuman PrescriptionRemedyrepack Inc.2015-01-071617860131
1094fa2258-577a-4097-9224-7b1df1885ccc (view SPL)Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Suspension, USPSterileprescriptionHuman PrescriptionRemedyrepack Inc.2013-11-221521250271
1199d9030f-9118-412c-a377-d1df1c8fa723 (view SPL)Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Suspension, USP SterileprescriptionHuman PrescriptionSandoz IncMANUFACTURE2011-08-164613140645
12aa6d6ba9-73af-4918-ac3c-0a2c1078f605 (view SPL)Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension USP (Sterile)prescriptionHuman PrescriptionRemedyrepack Inc.2013-11-221521250602
13b0ee85dd-5fe1-46a3-9bff-606e489d20b1 (view SPL)Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension USP (Sterile)prescriptionHuman PrescriptionBausch & Lomb IncorporatedAPI MANUFACTURE, MANUFACTURE2013-09-204242080635
14c03c099d-dd34-4731-8f50-ec5c7126f7de (view SPL)Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Suspension, USPSterileprescriptionHuman PrescriptionRemedyrepack Inc.2013-06-131521250271
15cb105db7-ab14-4b10-8a19-58bcb5eb27cd (view SPL)NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONEprescriptionHuman PrescriptionDirect Rxrelabel, repack2015-03-051619190662
16f8dc2b6f-daf3-4a3a-b31f-b97e2f152eae (view SPL)Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension USP (Sterile)prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2014-05-132687889924

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