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Abbreviated New Drug Application (ANDA): 209944
Company: SUNSHINE LAKE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
APIXABAN APIXABAN 2.GMG TABLET;ORAL None (Tentative Approval) None No No
APIXABAN APIXABAN 5MG TABLET;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
09/10/2019 ORIG-1 Tentative Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209944Orig1s000TAltr.pdf
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