Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091206
Company: PLIVA HRVATSKA DOO

Products on ANDA 091206

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BIVALIRUDIN	BIVALIRUDIN	250MG/VIAL	INJECTABLE;INTRAVENOUS	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091206

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/14/2016	ORIG-1	Tentative Approval				Label is not available on this site.