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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206551
Company: ACCORD HLTHCARE

Products on ANDA 206551

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 206551

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/22/2017	ORIG-1	Approval		STANDARD	Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206551Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206551Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 206551

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

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