Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206576
Company: TWI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET, EXTENDED RELEASE;ORAL None (Tentative Approval) None No No
OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET, EXTENDED RELEASE;ORAL None (Tentative Approval) None No No
OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET, EXTENDED RELEASE;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
11/29/2018 ORIG-1 Tentative Approval STANDARD

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