FDA Orange Book · active-ingredient family
Neomycin sulfate
Neomycin sulfate is approved as 1 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MYCIFRADIN · NDA 050285
1
Brand (NDA)
12
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MYCIFRADIN | PHARMACIA AND UPJOHN | NDA 050285 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (12)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NEOMYCIN SULFATE | CHARTWELL MOLECULAR | ANDA 204435 | — | Jun 10, 2016 | |
| NEOMYCIN SULFATE | PHARMOBEDIENT | ANDA 065468 | — | Mar 29, 2010 | |
| NEOMYCIN SULFATE | SOLARIS PHARMA CORP | ANDA 065220 | AA | Jul 28, 2006 | |
| NEO-FRADIN | X GEN PHARMS | ANDA 065010 | — | May 23, 2002 | |
| MYCIFRADIN | PHARMACIA AND UPJOHN | ANDA 060520 | — | Approved Prior to Jan 1, 1982 | |
| NEOBIOTIC | PFIZER | ANDA 060475 | — | Approved Prior to Jan 1, 1982 | |
| NEOMYCIN SULFATE | BRISTOL MYERS SQUIBB | ANDA 060365 | — | Approved Prior to Jan 1, 1982 | |
| NEOMYCIN SULFATE | LANNETT | ANDA 060607 | — | Approved Prior to Jan 1, 1982 | |
| NEOMYCIN SULFATE | LILLY | ANDA 060385 | — | Approved Prior to Jan 1, 1982 | |
| NEOMYCIN SULFATE | ROXANE | ANDA 062173 | — | Approved Prior to Jan 1, 1982 | |
| NEOMYCIN SULFATE | SANDOZ | ANDA 061586 | — | Approved Prior to Jan 1, 1982 | |
| NEOMYCIN SULFATE | TEVA | ANDA 060304 | AA | 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.
Neomycin sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
