FDA Orange Book · active-ingredient family
Dexamethasone sodium phosphate; neomycin sulfate
Dexamethasone sodium phosphate; neomycin sulfate is approved as 2 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NEODECADRON · NDA 050324
2
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · ointment, solution/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NEODECADRON | MERCK | NDA 050324 | — | Approved Prior to Jan 1, 1982 | |
| NEODECADRON | MERCK | NDA 050322 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE | BAUSCH AND LOMB | ANDA 064055 | — | Oct 30, 1995 | |
| NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE | ALCON PHARMS LTD | ANDA 062714 | — | Jul 21, 1986 | |
| NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE | PHARMAFAIR | ANDA 062539 | — | Jan 10, 1985 |
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 sodium phosphate; neomycin sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
