FDA Orange Book · active-ingredient family
Gramicidin; neomycin sulfate; polymyxin b sulfate
Gramicidin; neomycin sulfate; polymyxin b sulfate is approved in 7 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | SCIEGEN PHARMS | ANDA 065187 | AT | Oct 28, 2005 | |
| NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | BAUSCH AND LOMB INC | ANDA 064047 | AT | Jan 31, 1996 | |
| NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | IPHARM | ANDA 062818 | — | Oct 11, 1988 | |
| NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | WATSON LABS | ANDA 062788 | — | Jun 11, 1987 | |
| NEOMYCIN SULFATE AND POLYMYXIN B SULFATE GRAMICIDIN | PHARMAFAIR | ANDA 062383 | — | Aug 31, 1982 | |
| NEO-POLYCIN | DOW PHARM | ANDA 060427 | — | Approved Prior to Jan 1, 1982 | |
| NEOSPORIN | MONARCH PHARMS | ANDA 060582 | — | 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.
Gramicidin; neomycin sulfate; polymyxin b sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
