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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090811
Company: HOSPIRA

Products on ANDA 090811

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 090811

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/14/2015	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/090811s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090811Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/22/2019	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
11/22/2019	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
11/22/2019	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/22/2019	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 090811

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/14/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/090811s000lbl.pdf

Therapeutic Equivalents for ANDA 090811

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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