Orange Book product · Brand (NDA)
ZITUVIMET XR
METFORMIN HYDROCHLORIDE; SITAGLIPTIN
At a glance
Jul 18, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 18, 2024
1 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
METFORMIN HYDROCHLORIDE; SITAGLIPTIN
Strength
1GM;50MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 216778
Product number
002
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
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.
