FDA Orange Book · active-ingredient family
Vancomycin
Vancomycin is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:VANCOMYCIN · NDA 213895
1
Brand (NDA)
0
Generics (ANDA)
5
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VANCOMYCINRLD | HIKMA | NDA 213895 | — | Aug 26, 2021 |
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11517609 | Nov 06, 2035 | in 9 yr 6 mo | U-282 |
| 10188697 | Nov 06, 2035 | in 9 yr 6 mo | ProductU-282 |
| 10039804 | Nov 06, 2035 | in 9 yr 6 mo | ProductU-282 |
| 10849956 | Nov 06, 2035 | in 9 yr 6 mo | Product |
| 11000567 | Nov 06, 2035 | in 9 yr 6 mo | Product |
Vancomycin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
