Orange Book product · Brand (NDA)
ZITUVIO
SITAGLIPTIN
Brand (NDA)NDA 211566RX ZYDUS LIFESCIENCES
At a glance
Oct 18, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 18, 2023
2 yr 9 mo ago
Today
Patent 10925871 expires
Listed drug product patent expiration.
Feb 25, 2035
in 8 yr 10 mo
Pharmaceutical detail
Active ingredient
SITAGLIPTIN
Strength
25MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 211566
Product number
001
Marketing status
RX
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 (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10925871 | Feb 25, 2035 | in 8 yr 10 mo | Product |
