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Abbreviated New Drug Application (ANDA): 210073
Company: SUNSHINE LAKE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALOGLIPTIN ALOGLIPTIN UNKNOWN UNKNOWN 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
01/06/2021 ORIG-1 Tentative Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210073Orig1s000TA_ltr.pdf
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