FDA Orange Book · active-ingredient family
Polymyxin b sulfate
Polymyxin b sulfate is approved in 10 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| POLYMYXIN B SULFATE | GLAND | ANDA 207322 | AP | Apr 14, 2016 | |
| POLYMYXIN B SULFATE | EUGIA PHARMA | ANDA 206589 | AP | Apr 04, 2016 | |
| POLYMYXIN B SULFATE | XELLIA PHARMS APS | ANDA 202766 | AP | Jan 15, 2014 | |
| POLYMYXIN B SULFATE | RISING | ANDA 090110 | — | Jun 29, 2011 | |
| POLYMYXIN B SULFATE | FRESENIUS KABI USA | ANDA 065372 | AP | Jan 10, 2008 | |
| POLYMYXIN B SULFATE | PHARMOBEDIENT | ANDA 063000 | — | Sep 30, 1994 | |
| POLYMYXIN B SULFATE | PADDOCK LLC | ANDA 062455 | — | Jul 27, 1983 | |
| AEROSPORIN | GLAXOSMITHKLINE | ANDA 062036 | — | Approved Prior to Jan 1, 1982 | |
| POLYMYXIN B SULFATE | HIKMA | ANDA 060716 | — | Approved Prior to Jan 1, 1982 | |
| POLY-RX | X GEN PHARMS | ANDA 061578 | — | 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.
Polymyxin b sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
