Orange Book product · Generic (ANDA)
TIROFIBAN HYDROCHLORIDE
TIROFIBAN HYDROCHLORIDE
Generic (ANDA)ANDA 216379TE APRX EUGIA PHARMA
At a glance
May 01, 2023
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 01, 2023
3 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
TIROFIBAN HYDROCHLORIDE
Strength
EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
ANDA 216379
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of TIROFIBAN HYDROCHLORIDE
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.
