FDA Orange Book · active-ingredient family
Bacitracin zinc; neomycin sulfate; polymyxin b sulfate
Bacitracin zinc; neomycin sulfate; polymyxin b sulfate is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LUMI-SPORYN · NDA 050417
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · ointment
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LUMI-SPORYNRLD | CASPER PHARMA LLC | NDA 050417 | AT | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC | SCIEGEN PHARMS | ANDA 065088 | — | Feb 06, 2004 | |
| NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC | BAUSCH AND LOMB INC | ANDA 064064 | AT | Oct 30, 1995 | |
| BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE | NASKA | ANDA 062833 | — | Nov 09, 1987 | |
| BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE | PHARMAFAIR | ANDA 062386 | — | Sep 09, 1982 | |
| BACITRACIN-NEOMYCIN-POLYMYXIN | PHARMADERM | ANDA 062167 | — | Approved Prior to Jan 1, 1982 | |
| NEO-POLYCIN | DOW PHARM | ANDA 060647 | — | Approved Prior to Jan 1, 1982 | |
| NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC | PADAGIS US | ANDA 060764 | — | 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.
Bacitracin zinc; neomycin sulfate; polymyxin b sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
