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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207864
Company: HYBIO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EPTIFIBATIDE EPTIFIBATIDE 2MG/ML INJECTABLE;INJECTION Discontinued None No No
EPTIFIBATIDE EPTIFIBATIDE 75MG/100ML INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/20/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

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