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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205857
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BORTEZOMIB BORTEZOMIB 3.5MG/VIAL INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 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
05/02/2022 ORIG-1 Approval STANDARD

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