Orange Book product · Generic (ANDA)
BIVALIRUDIN
BIVALIRUDIN
At a glance
Oct 23, 2019
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 23, 2019
6 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
BIVALIRUDIN
Strength
250MG/VIAL
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
AP
Application
ANDA 210031
Product number
001
Marketing status
RX
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
- 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
- 2015BIVALIRUDINGeneric (ANDA)
ANDA 090811 · HOSPIRA
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.
