Orange Book product · Brand (NDA)
KOMBIGLYZE XR
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
At a glance
Nov 05, 2010
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 05, 2010
15 yr 10 mo ago
Today
Exclusivity ends · M-14
New use / labeling-change exclusivity (3 years)
Oct 11, 2027
in 1 yr 4 mo
Pharmaceutical detail
Active ingredient
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Strength
1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 200678
Product number
003
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.
Marketing exclusivity (1)
- M-14New use / labeling-change exclusivity (3 years)
Oct 11, 2027
in 1 yr 4 mo
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.
