Orange Book product · Brand (NDA)
INTEGRILIN
EPTIFIBATIDE
At a glance
May 18, 1998
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 18, 1998
28 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
EPTIFIBATIDE
Strength
75MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 020718
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.
- 2024EPTIFIBATIDEGeneric (ANDA)
ANDA 213599 · MEITHEAL
- 2021EPTIFIBATIDEGeneric (ANDA)
ANDA 213081 · SHUANGCHENG
- 2020EPTIFIBATIDEGeneric (ANDA)
ANDA 207864 · HYBIO
- 2019EPTIFIBATIDEGeneric (ANDA)
ANDA 204361 · USV
- 2019EPTIFIBATIDEGeneric (ANDA)
ANDA 204362 · USV
- 2019EPTIFIBATIDEGeneric (ANDA)
ANDA 209864 · SLATE RUN PHARMA
- 2018EPTIFIBATIDEGeneric (ANDA)
ANDA 208554 · BAXTER HLTHCARE CORP
- 2018EPTIFIBATIDEGeneric (ANDA)
ANDA 203258 · MYLAN LABS LTD
- 2018EPTIFIBATIDEGeneric (ANDA)
ANDA 204693 · SAGENT PHARMS INC
- 2017EPTIFIBATIDEGeneric (ANDA)
ANDA 205557 · ACCORD HLTHCARE
- 2017EPTIFIBATIDEGeneric (ANDA)
ANDA 204589 · RISING
- 2016EPTIFIBATIDEGeneric (ANDA)
ANDA 205581 · AMNEAL PHARMS
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.
