FDA Orange Book · active-ingredient family
Neomycin sulfate; polymyxin b sulfate
Neomycin sulfate; polymyxin b sulfate is approved as 3 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NEOSPORIN · NDA 050176
3
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, ointment, solution, solution/drops
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NEOMYCIN AND POLYMYXIN B SULFATE | XGEN PHARMS | ANDA 065106 | — | Jan 31, 2006 | |
| NEOMYCIN AND POLYMYXIN B SULFATE | XGEN PHARMS | ANDA 065108 | — | Jan 31, 2006 | |
| NEOMYCIN AND POLYMYXIN B SULFATE | WATSON LABS | ANDA 062664 | — | Apr 08, 1986 | |
| STATROL | ALCON | ANDA 062339 | — | Nov 30, 1984 | |
| NEOSPORIN G.U. IRRIGANT | MONARCH PHARMS | ANDA 060707 | — | 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.
Neomycin sulfate; polymyxin b sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
