Orange Book product · Brand (NDA)
VARITHENA
POLIDOCANOL
Brand (NDA)NDA 205098DISCN BOSTON SCITFC
At a glance
Dec 21, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 21, 2017
8 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
POLIDOCANOL
Strength
77.5MG/7.75ML (10MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 205098
Product number
002
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.
