FDA Orange Book · active-ingredient family
Dexamethasone; neomycin sulfate; polymyxin b sulfate
Dexamethasone; neomycin sulfate; polymyxin b sulfate is approved as 2 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MAXITROL · NDA 050065
2
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · ointment, suspension/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MAXITROLRLD | SANDOZ | NDA 050065 | AT | Approved Prior to Jan 1, 1982 | |
| MAXITROLRLD | HARROW EYE | NDA 050023 | AT | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DEXASPORIN | BAUSCH AND LOMB INC | ANDA 064135 | AT | Sep 13, 1995 | |
| NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE | BAUSCH AND LOMB INC | ANDA 064063 | AT | Jul 25, 1994 | |
| NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE | PADAGIS US | ANDA 062938 | — | Jul 31, 1989 | |
| NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE | ALCON PHARMS LTD | ANDA 062721 | — | Nov 17, 1986 | |
| DEXACIDIN | NOVARTIS | ANDA 062566 | — | Feb 22, 1985 | |
| DEXACIDIN | NOVARTIS | ANDA 062544 | — | Oct 29, 1984 | |
| MAXITROL | SANDOZ | ANDA 062341 | AT | May 22, 1984 | |
| DEXASPORIN | PHARMAFAIR | ANDA 062428 | — | May 18, 1983 | |
| DEXASPORIN | PHARMAFAIR | ANDA 062411 | — | May 16, 1983 |
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.
Dexamethasone; neomycin sulfate; polymyxin b sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
