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Abbreviated New Drug Application (ANDA): 208443
Company: ACTAVIS LABS FL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FIDAXOMICIN FIDAXOMICIN 200MG TABLET;ORAL Discontinued 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
01/16/2024 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208443Orig1s000ltr.pdf
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