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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205942
Company: AMNEAL PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SAXAGLIPTIN;METFORMIN HYDROCHLORIDE SAXAGLIPTIN;METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE;ORAL None (Tentative Approval) None No No
SAXAGLIPTIN;METFORMIN HYDROCHLORIDE SAXAGLIPTIN;METFORMIN HYDROCHLORIDE 2.5MG;1000MG TABLET, EXTENDED RELEASE;ORAL None (Tentative Approval) None No No
SAXAGLIPTIN;METFORMIN HYDROCHLORIDE SAXAGLIPTIN;METFORMIN HYDROCHLORIDE 5MG;1000MG 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
01/21/2016 ORIG-1 Tentative Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205942Orig1s000TAltr.pdf
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