An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090189
Company: FRESENIUS KABI USA

Products on ANDA 090189

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BIVALIRUDIN	BIVALIRUDIN	250MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090189

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/28/2016	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090189Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/14/2021	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090189

BIVALIRUDIN

INJECTABLE;INTRAVENOUS; 250MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ANGIOMAX	BIVALIRUDIN	250MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	020873	SANDOZ
BIVALIRUDIN	BIVALIRUDIN	250MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	206551	ACCORD HLTHCARE
BIVALIRUDIN	BIVALIRUDIN	250MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	201577	DR REDDYS
BIVALIRUDIN	BIVALIRUDIN	250MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	205962	EUGIA PHARMA
BIVALIRUDIN	BIVALIRUDIN	250MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	090189	FRESENIUS KABI USA
BIVALIRUDIN	BIVALIRUDIN	250MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	090811	HOSPIRA
BIVALIRUDIN	BIVALIRUDIN	250MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	090816	HOSPIRA
BIVALIRUDIN	BIVALIRUDIN	250MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	091602	MEITHEAL
BIVALIRUDIN	BIVALIRUDIN	250MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	202471	MYLAN INSTITUTIONAL
BIVALIRUDIN	BIVALIRUDIN	250MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	210031	SHUANGCHENG
BIVALIRUDIN	BIVALIRUDIN	250MG/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	213078	SLATE RUN PHARMA

Top