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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216228
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PALIPERIDONE PALMITATE PALIPERIDONE PALMITATE 273MG/0.88ML SUSPENSION, EXTENDED RELEASE;INJECTABLE None (Tentative Approval) None No No
PALIPERIDONE PALMITATE PALIPERIDONE PALMITATE 410MG/1.32ML SUSPENSION, EXTENDED RELEASE;INJECTABLE 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
05/20/2024 ORIG-1 Tentative Approval STANDARD

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