FDA Orange Book · active-ingredient family
Bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate
Bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate is approved as 2 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CORTISPORIN · NDA 050168
2
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · ointment
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CORTISPORINRLD | MONARCH PHARMS | NDA 050168 | — | May 04, 1984 | |
| CORTISPORINRLD | CASPER PHARMA LLC | NDA 050416 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE | SCIEGEN PHARMS | ANDA 065213 | — | Jul 25, 2012 | |
| NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE | BAUSCH AND LOMB INC | ANDA 064068 | — | Oct 30, 1995 | |
| NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE | PHARMAFAIR | ANDA 062381 | — | Sep 06, 1985 | |
| ZINC BACITRACIN,NEOMYCIN SULFATE,POLYMYXIN B SULFATE & HYDROCORTISONE | PHARMAFAIR | ANDA 062389 | — | Jul 02, 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.
Bacitracin zinc; 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.
