FDA Orange Book · active-ingredient family
Polymyxin b sulfate; trimethoprim sulfate
Polymyxin b sulfate; trimethoprim sulfate is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:POLYTRIM · NDA 050567
1
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| POLYTRIMRLD | ALLERGAN | NDA 050567 | — | Oct 20, 1988 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | SOMERSET THERAPS LLC | ANDA 211572 | AT | Aug 05, 2024 | |
| TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | EPIC PHARMA LLC | ANDA 065006 | AT | Dec 17, 1998 | |
| TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | SANDOZ | ANDA 064211 | AT | Apr 13, 1998 | |
| TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | BAUSCH AND LOMB INC | ANDA 064120 | AT | Feb 14, 1997 |
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; trimethoprim sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
