FDA Orange Book · active-ingredient family
Bacitracin zinc; polymyxin b sulfate
Bacitracin zinc; polymyxin b sulfate is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:POLYSPORIN · NDA 050167
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · aerosol, ointment
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| POLYSPORIN | GLAXOSMITHKLINE | NDA 050167 | — | Mar 01, 1985 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BACITRACIN ZINC AND POLYMYXIN B SULFATE | PADAGIS US | ANDA 065022 | — | Feb 27, 2002 | |
| BACITRACIN ZINC AND POLYMYXIN B SULFATE | SCIEGEN PHARMS | ANDA 064028 | — | Jan 30, 1995 | |
| BACITRACIN ZINC AND POLYMYXIN B SULFATE | BAUSCH AND LOMB INC | ANDA 064046 | — | Jan 26, 1995 | |
| BACITRACIN ZINC-POLYMYXIN B SULFATE | NASKA | ANDA 062849 | — | Nov 13, 1987 | |
| OCUMYCIN | PHARMAFAIR | ANDA 062430 | — | Apr 08, 1983 | |
| POLYSPORIN | MONARCH PHARMS | ANDA 061229 | — | 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; polymyxin b sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
