FDA Orange Book · active-ingredient family
Hydrocortisone; neomycin sulfate; polymyxin b sulfate
Hydrocortisone; neomycin sulfate; polymyxin b sulfate is approved as 3 brand and 17 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CORTISPORIN · NDA 050479
3
Brand (NDA)
17
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution/drops, suspension/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CORTISPORINRLD | MONARCH PHARMS | NDA 050479 | — | Approved Prior to Jan 1, 1982 | |
| CASPORYN HCRLD | CASPER PHARMA LLC | NDA 060613 | AT | Approved Prior to Jan 1, 1982 | |
| CORTISPORIN | MONARCH PHARMS | NDA 050169 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (17)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | AMNEAL | ANDA 217803 | AT | Oct 29, 2025 | |
| NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | AMNEAL | ANDA 217735 | AT | Sep 30, 2025 | |
| NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | SCIEGEN PHARMS | ANDA 065219 | AT | May 01, 2006 | |
| NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | SAPTALIS PHARMS | ANDA 065216 | — | Oct 31, 2005 | |
| OTICAIR | BAUSCH AND LOMB INC | ANDA 064065 | AT | Aug 28, 1996 | |
| NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | BAUSCH AND LOMB INC | ANDA 064053 | AT | Dec 29, 1995 | |
| NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | SANDOZ | ANDA 062874 | — | May 11, 1988 | |
| PEDIOTIC | MONARCH PHARMS | ANDA 062822 | — | Sep 29, 1987 | |
| NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | SANDOZ | ANDA 062488 | AT | Nov 06, 1985 | |
| NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE | PHARMAFAIR | ANDA 062623 | — | Sep 24, 1985 | |
| NEOMYCIN SULFATE, POLYMYXIN B SULFATE & HYDROCORTISONE | PHARMAFAIR | ANDA 062617 | — | Sep 18, 1985 | |
| OTOCORT | WATSON LABS | ANDA 062521 | — | Jul 11, 1985 | |
| NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | SANDOZ | ANDA 062423 | AT | Aug 25, 1983 | |
| OTICAIR | PHARMAFAIR | ANDA 062399 | — | Nov 18, 1982 | |
| NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE | PHARMAFAIR | ANDA 062394 | — | Sep 29, 1982 | |
| OTOCORT | WATSON LABS | ANDA 060730 | — | Approved Prior to Jan 1, 1982 | |
| OTOBIONE | SCHERING | ANDA 061816 | — | Approved Prior to Jan 1, 1982 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Hydrocortisone; neomycin sulfate; polymyxin b sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
