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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205444
Company: ACTAVIS LABS FL 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
07/19/2018 ORIG-1 Tentative Approval STANDARD Letter (PDF)

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 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205444Orig1s000TAltr.pdf
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