Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207551
Company: AMNEAL PHARMS CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION None (Tentative Approval) None No No
DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION 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
03/29/2018 ORIG-1 Tentative Approval STANDARD

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