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)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 242080635 | ANDA | Bausch & Lomb Incorporated | 1996-08-28 | HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | AURICULAR (OTIC) | SUSPENSION/DROPS | ANDA064065 | b0ee85dd-5fe1-46a3-9bff-606e489d20b1 |
| 2 | 613140645 | ANDA | Sandoz Inc | 2003-03-17 | HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | AURICULAR (OTIC) | SUSPENSION | ANDA062488 | 99d9030f-9118-412c-a377-d1df1c8fa723 |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 009043017 | Cortomycin | ANDA | Major | 1996-08-28 | HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | AURICULAR (OTIC) | SUSPENSION/DROPS | 009043017 | ANDA064065 | 41cfa382-d4ae-43c5-83a5-1ecc635d109b |
| 2 | 216950438 | ANDA | Rebel Distributors Corp | 1995-12-29 | HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | AURICULAR (OTIC) | SUSPENSION/DROPS | 242080635 | ANDA064053 | 595ee3ac-2f33-4459-87ff-be002928059c | |
| 3 | 521250271 | ANDA | Remedyrepack Inc. | 2013-06-13, 2013-11-22 | HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | AURICULAR (OTIC) | SUSPENSION | 613140645 | ANDA062488 | 94fa2258-577a-4097-9224-7b1df1885ccc, c03c099d-dd34-4731-8f50-ec5c7126f7de | |
| 4 | 521250602 | ANDA | Remedyrepack Inc. | 2013-06-06, 2013-11-22 | HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | AURICULAR (OTIC) | SUSPENSION/DROPS | 242080635 | ANDA064065 | 68d07fc1-a8ab-4b49-96c2-706b91ba82e0, aa6d6ba9-73af-4918-ac3c-0a2c1078f605 | |
| 5 | 521250746 | ANDA | Remedyrepack Inc. | 2013-10-15 | HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | AURICULAR (OTIC) | SUSPENSION/DROPS | 242080635 | ANDA064065 | 6dda5239-b0be-42e5-860e-cd58406d50cb | |
| 6 | 529590084 | ANDA | H.J. Harkins Company, Inc. | 1996-08-28 | HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | AURICULAR (OTIC) | SUSPENSION/DROPS | 242080635 | ANDA064065 | 02b16b3c-5276-4c5c-affa-9e08d99667b0 | |
| 7 | 545693259 | ANDA | A-S Medication Solutions Llc | 1996-08-28 | HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | AURICULAR (OTIC) | SUSPENSION/DROPS | 242080635 | ANDA064065 | 761d7ce5-8730-429f-a3bf-ff3092ca0fae | |
| 8 | 581189931 | ANDA | Clinical Solutions Wholesale | 1996-08-28 | HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | AURICULAR (OTIC) | SUSPENSION/DROPS | 242080635 | ANDA064065 | 5cc96e4f-81d1-4ce0-a6ea-c201f39f71c2 | |
| 9 | 617860131 | ANDA | Remedyrepack Inc. | 2015-01-07 | HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | AURICULAR (OTIC) | SUSPENSION | 613140645 | ANDA062488 | 8bfc882e-ce38-4b27-846c-da47077bfba0 | |
| 10 | 619190662 | ANDA | Direct Rx | 2014-01-01 | HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | AURICULAR (OTIC) | SUSPENSION/DROPS | 242080635 | ANDA064065 | cb105db7-ab14-4b10-8a19-58bcb5eb27cd | |
| 11 | 687889415 | ANDA | Preferred Pharmaceuticals, Inc. | 2014-05-13 | HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | AURICULAR (OTIC) | SUSPENSION | 613140645 | ANDA062488 | 85f47a6f-bd76-4369-bcb4-e70281a0ec28 | |
| 12 | 687889924 | ANDA | Preferred Pharmaceuticals, Inc. | 2012-01-18 | HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | AURICULAR (OTIC) | SUSPENSION/DROPS | 242080635 | ANDA064065 | f8dc2b6f-daf3-4a3a-b31f-b97e2f152eae |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug | in other drug docs |
|---|---|---|---|---|---|---|---|
| 1 | ANDA060730 | OTOCORT | True | WATSON LABORATORIES INC | ANDA060730_002 | Hydrocortisone / Neomycin / Polymyxin B Otic Solution Hydrocortisone / Neomycin / Polymyxin B Ophthalmic Suspension | |
| 2 | ANDA061816 | OTOBIONE | True | SCHERING CORP SUB SCHERING PLOUGH CORP | ANDA061816_001 | ||
| 3 | ANDA062394 | NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE | True | PHARMAFAIR INC | 1982-09-29 | ANDA062394_001 | Hydrocortisone / Neomycin / Polymyxin B Otic Solution Hydrocortisone / Neomycin / Polymyxin B Ophthalmic Suspension |
| 4 | ANDA062399 | OTICAIR | True | PHARMAFAIR INC | 1982-11-18 | ANDA062399_001 | |
| 5 | ANDA062423 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | ALCON PHARMACEUTICALS LTD | 1983-08-25 | ANDA062423_001 | Hydrocortisone / Neomycin / Polymyxin B Otic Solution Hydrocortisone / Neomycin / Polymyxin B Ophthalmic Suspension | |
| 6 | ANDA062488 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | ALCON PHARMACEUTICALS LTD | 1985-11-06 | ANDA062488_001 | ||
| 7 | ANDA062521 | OTOCORT | True | ACTAVIS LABORATORIES FL INC | 1985-07-11 | ANDA062521_001 | |
| 8 | ANDA062617 | NEOMYCIN SULFATE, POLYMYXIN B SULFATE & HYDROCORTISONE | True | PHARMAFAIR INC | 1985-09-18 | ANDA062617_001 | |
| 9 | ANDA062822 | PEDIOTIC | MONARCH PHARMACEUTICALS INC | 1987-09-29 | ANDA062822_001 | ||
| 10 | ANDA064053 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | BAUSCH AND LOMB PHARMACEUTICALS INC | 1995-12-29 | ANDA064053_001 | Hydrocortisone / Neomycin / Polymyxin B Otic Solution Hydrocortisone / Neomycin / Polymyxin B Ophthalmic Suspension | |
| 11 | ANDA064065 | OTICAIR | BAUSCH AND LOMB PHARMACEUTICALS INC | 1996-08-28 | ANDA064065_001 | ||
| 12 | ANDA065216 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | LUITPOLD PHARMACEUTICALS INC | 2005-10-31 | ANDA065216_001 | Hydrocortisone / Neomycin / Polymyxin B Otic Solution Hydrocortisone / Neomycin / Polymyxin B Ophthalmic Suspension | |
| 13 | ANDA065219 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | LUITPOLD PHARMACEUTICALS INC | 2006-05-01 | ANDA065219_001 | ||
| 14 | NDA050479 | CORTISPORIN | MONARCH PHARMACEUTICALS INC | NDA050479_001 | Hydrocortisone / Neomycin / Polymyxin B Otic Solution Hydrocortisone / Neomycin / Polymyxin B Ophthalmic Suspension | ||
| 15 | NDA060613 | CORTISPORIN | CITRON PHARMA LLC | NDA060613_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA060730_002 | discontinued | POLYMYXIN B SULFATE (10,000 UNITS/ML), HYDROCORTISONE (1%), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML) | SOLUTION/DROPS | False | OTOCORT | ||
| 2 | ANDA061816_001 | discontinued | POLYMYXIN B SULFATE (10,000 UNITS/ML), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML), HYDROCORTISONE (1%) | SUSPENSION/DROPS | False | OTOBIONE | ||
| 3 | ANDA062394_001 | discontinued | HYDROCORTISONE (1%), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML), POLYMYXIN B SULFATE (10,000 UNITS/ML) | SOLUTION/DROPS | False | 1982-09-29 | NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE | |
| 4 | ANDA062399_001 | discontinued | NEOMYCIN SULFATE (EQ 3.5MG BASE/ML), HYDROCORTISONE (1%), POLYMYXIN B SULFATE (10,000 UNITS/ML) | SUSPENSION/DROPS | False | 1982-11-18 | OTICAIR | |
| 5 | ANDA062423_001 | RX | NEOMYCIN SULFATE (EQ 3.5MG BASE/ML), POLYMYXIN B SULFATE (10,000 UNITS/ML), HYDROCORTISONE (1%) | SOLUTION/DROPS | False | AT | 1983-08-25 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE |
| 6 | ANDA062488_001 | RX | POLYMYXIN B SULFATE (10,000 UNITS/ML), HYDROCORTISONE (1%), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML) | SUSPENSION/DROPS | False | AT | 1985-11-06 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE |
| 7 | ANDA062521_001 | discontinued | NEOMYCIN SULFATE (EQ 3.5MG BASE/ML), HYDROCORTISONE (1%), POLYMYXIN B SULFATE (10,000 UNITS/ML) | SUSPENSION/DROPS | False | 1985-07-11 | OTOCORT | |
| 8 | ANDA062617_001 | discontinued | HYDROCORTISONE (1%), POLYMYXIN B SULFATE (10,000 UNITS/ML), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML) | SUSPENSION/DROPS | False | 1985-09-18 | NEOMYCIN SULFATE, POLYMYXIN B SULFATE & HYDROCORTISONE | |
| 9 | ANDA062822_001 | RX | POLYMYXIN B SULFATE (10,000 UNITS/ML), HYDROCORTISONE (1%), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML) | SUSPENSION/DROPS | False | AT | 1987-09-29 | PEDIOTIC |
| 10 | ANDA064053_001 | RX | NEOMYCIN SULFATE (EQ 3.5MG BASE/ML), HYDROCORTISONE (1%), POLYMYXIN B SULFATE (10,000 UNITS/ML) | SOLUTION/DROPS | False | AT | 1995-12-29 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE |
| 11 | ANDA064065_001 | RX | HYDROCORTISONE (1%), POLYMYXIN B SULFATE (10,000 UNITS/ML), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML) | SUSPENSION/DROPS | False | AT | 1996-08-28 | OTICAIR |
| 12 | ANDA065216_001 | RX | POLYMYXIN B SULFATE (10,000 UNITS/ML), HYDROCORTISONE (1%), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML) | SOLUTION/DROPS | False | AT | 2005-10-31 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE |
| 13 | ANDA065219_001 | RX | POLYMYXIN B SULFATE (10,000 UNITS/ML), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML), HYDROCORTISONE (1%) | SUSPENSION/DROPS | False | AT | 2006-05-01 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE |
| 14 | NDA050479_001 | RX | POLYMYXIN B SULFATE (10,000 UNITS/ML), HYDROCORTISONE (1%), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML) | SOLUTION/DROPS | True | AT | CORTISPORIN | |
| 15 | NDA060613_001 | RX | POLYMYXIN B SULFATE (10,000 UNITS/ML), NEOMYCIN SULFATE (EQ 3.5MG BASE/ML), HYDROCORTISONE (1%) | SUSPENSION/DROPS | True | AT | CORTISPORIN |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 02b16b3c-5276-4c5c-affa-9e08d99667b0 (view SPL) | Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension USP (Sterile) | prescription | Human Prescription | H.J. Harkins Company, Inc. | relabel, repack | 2012-04-20 | 5 | 529590084 |
| 2 | 41cfa382-d4ae-43c5-83a5-1ecc635d109b (view SPL) | Neomycin and Polymyxin B Sulfates and Hydrocortisone | prescription | Human Prescription | Major | 2009-08-31 | 1 | 009043017 | |
| 3 | 595ee3ac-2f33-4459-87ff-be002928059c (view SPL) | Neomycin and Polymyxin B Sulfatesand Hydrocortisone Otic Suspension USP | prescription | Human Prescription | Rebel Distributors Corp | RELABEL, REPACK | 2010-10-08 | 1 | 216950438 |
| 4 | 5cc96e4f-81d1-4ce0-a6ea-c201f39f71c2 (view SPL) | Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension USP (Sterile) | prescription | Human Prescription | Clinical Solutions Wholesale | RELABEL | 2013-11-18 | 1 | 581189931 |
| 5 | 68d07fc1-a8ab-4b49-96c2-706b91ba82e0 (view SPL) | Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension USP (Sterile) | prescription | Human Prescription | Remedyrepack Inc. | 2013-06-06 | 1 | 521250602 | |
| 6 | 6dda5239-b0be-42e5-860e-cd58406d50cb (view SPL) | Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension USP (Sterile) | prescription | Human Prescription | Remedyrepack Inc. | 2013-10-15 | 1 | 521250746 | |
| 7 | 761d7ce5-8730-429f-a3bf-ff3092ca0fae (view SPL) | Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension USP (Sterile) | prescription | Human Prescription | A-S Medication Solutions Llc | relabel | 2013-10-26 | 1 | 545693259 |
| 8 | 85f47a6f-bd76-4369-bcb4-e70281a0ec28 (view SPL) | Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Suspension, USP Sterile | prescription | Human Prescription | Preferred Pharmaceuticals, Inc. | RELABEL | 2015-11-10 | 2 | 687889415 |
| 9 | 8bfc882e-ce38-4b27-846c-da47077bfba0 (view SPL) | Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Suspension, USPSterile | prescription | Human Prescription | Remedyrepack Inc. | 2015-01-07 | 1 | 617860131 | |
| 10 | 94fa2258-577a-4097-9224-7b1df1885ccc (view SPL) | Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Suspension, USPSterile | prescription | Human Prescription | Remedyrepack Inc. | 2013-11-22 | 1 | 521250271 | |
| 11 | 99d9030f-9118-412c-a377-d1df1c8fa723 (view SPL) | Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Suspension, USP Sterile | prescription | Human Prescription | Sandoz Inc | MANUFACTURE | 2011-08-16 | 4 | 613140645 |
| 12 | aa6d6ba9-73af-4918-ac3c-0a2c1078f605 (view SPL) | Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension USP (Sterile) | prescription | Human Prescription | Remedyrepack Inc. | 2013-11-22 | 1 | 521250602 | |
| 13 | b0ee85dd-5fe1-46a3-9bff-606e489d20b1 (view SPL) | Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension USP (Sterile) | prescription | Human Prescription | Bausch & Lomb Incorporated | API MANUFACTURE, MANUFACTURE | 2013-09-20 | 4 | 242080635 |
| 14 | c03c099d-dd34-4731-8f50-ec5c7126f7de (view SPL) | Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Suspension, USPSterile | prescription | Human Prescription | Remedyrepack Inc. | 2013-06-13 | 1 | 521250271 | |
| 15 | cb105db7-ab14-4b10-8a19-58bcb5eb27cd (view SPL) | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | prescription | Human Prescription | Direct Rx | relabel, repack | 2015-03-05 | 1 | 619190662 |
| 16 | f8dc2b6f-daf3-4a3a-b31f-b97e2f152eae (view SPL) | Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension USP (Sterile) | prescription | Human Prescription | Preferred Pharmaceuticals, Inc. | RELABEL | 2014-05-13 | 2 | 687889924 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII