Orange Book product · Brand (NDA)
VANCOMYCIN
VANCOMYCIN
At a glance
Aug 26, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 26, 2021
4 yr 11 mo ago
Today
Patent 10039804 expires
Listed drug product patent expiration.
Nov 06, 2035
in 9 yr 6 mo
Patent 10188697 expires
Listed drug product patent expiration.
Nov 06, 2035
in 9 yr 6 mo
Patent 10849956 expires
Listed drug product patent expiration.
Nov 06, 2035
in 9 yr 6 mo
Patent 11000567 expires
Listed drug product patent expiration.
Nov 06, 2035
in 9 yr 6 mo
Patent 11517609 expires
Listed method-of-use patent (U-282) expiration.
Nov 06, 2035
in 9 yr 6 mo
Pharmaceutical detail
Active ingredient
VANCOMYCIN
Strength
5GM/100ML (50MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS, ORAL
TE code
Not listed
Application
NDA 213895
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10039804 | Nov 06, 2035 | in 9 yr 6 mo | ProductU-282 |
| 10188697 | 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 |
| 11517609 | Nov 06, 2035 | in 9 yr 6 mo | U-282 |
