Orange Book product · Brand (NDA)
TEKTURNA
ALISKIREN HEMIFUMARATE
Brand (NDA)NDA 210709DISCN NODEN PHARMA
At a glance
Nov 14, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 14, 2017
8 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
ALISKIREN HEMIFUMARATE
Strength
EQ 37.5MG BASE
Dosage form
CAPSULE, PELLET
Route
ORAL
TE code
Not listed
Application
NDA 210709
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
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.
