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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206452
Company: CADILA PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREGABALIN PREGABALIN 25MG CAPSULE;ORAL None (Tentative Approval) None No No
PREGABALIN PREGABALIN 50MG CAPSULE;ORAL None (Tentative Approval) None No No
PREGABALIN PREGABALIN 75MG CAPSULE;ORAL None (Tentative Approval) None No No
PREGABALIN PREGABALIN 100MG CAPSULE;ORAL None (Tentative Approval) None No No
PREGABALIN PREGABALIN 150MG CAPSULE;ORAL None (Tentative Approval) None No No
PREGABALIN PREGABALIN 200MG CAPSULE;ORAL None (Tentative Approval) None No No
PREGABALIN PREGABALIN 225MG CAPSULE;ORAL None (Tentative Approval) None No No
PREGABALIN PREGABALIN 300MG CAPSULE;ORAL 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
12/27/2018 ORIG-1 Tentative Approval STANDARD

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