Orange Book product · Generic (ANDA)
BIVALIRUDIN
BIVALIRUDIN
At a glance
Jul 14, 2015
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 14, 2015
11 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
BIVALIRUDIN
Strength
250MG/VIAL
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
Not listed
Application
ANDA 090816
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of BIVALIRUDIN
- 2019ANGIOMAX RTUBrand (NDA)
NDA 211215 · MAIA PHARMS INC
- 2017BIVALIRUDIN IN 0.9% SODIUM CHLORIDEBrand (NDA)
NDA 208374 · BAXTER HLTHCARE CORP
- 2000ANGIOMAXBrand (NDA)
NDA 020873 · SANDOZ
- 2021BIVALIRUDINGeneric (ANDA)
ANDA 213078 · SLATE RUN PHARMA
- 2019BIVALIRUDINGeneric (ANDA)
ANDA 210031 · SHUANGCHENG
- 2018BIVALIRUDINGeneric (ANDA)
ANDA 205962 · EUGIA PHARMA
- 2018BIVALIRUDINGeneric (ANDA)
ANDA 091602 · MEITHEAL
- 2018BIVALIRUDINGeneric (ANDA)
ANDA 202471 · MYLAN INSTITUTIONAL
- 2017BIVALIRUDINGeneric (ANDA)
ANDA 206551 · ACCORD HLTHCARE
- 2017BIVALIRUDINGeneric (ANDA)
ANDA 204876 · APOTEX
- 2017BIVALIRUDINGeneric (ANDA)
ANDA 201577 · DR REDDYS
- 2016BIVALIRUDINGeneric (ANDA)
ANDA 090189 · FRESENIUS KABI USA
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.
