Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091468
Company: MYLAN LABS LTD

Products on ANDA 091468

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091468

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/02/2017	ORIG-1	Tentative Approval				Label is not available on this site.