Orange Book product · Brand (NDA)
AGGRASTAT
TIROFIBAN HYDROCHLORIDE
At a glance
Aug 31, 2016
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 31, 2016
9 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
TIROFIBAN HYDROCHLORIDE
Strength
EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)
Dosage form
SOLUTION
Route
INJECTION
TE code
Not listed
Application
NDA 020912
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
