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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213856
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REGADENOSON REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION;INTRAVENOUS None (Tentative Approval) 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
03/11/2022 ORIG-1 Tentative Approval STANDARD

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