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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202426
Company: APOTEX INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SITAGLIPTIN; METFORMIN HYDROCHLORIDE SITAGLIPTIN; METFORMIN HYDROCHLORIDE 50MG; 500MG TABLET; ORAL None (Tentative Approval) None No No
SITAGLIPTIN; METFORMIN HYDROCHLORIDE SITAGLIPTIN; METFORMIN HYDROCHLORIDE 50MG; 1000MG 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
03/10/2014 ORIG-1 Tentative Approval

Label is not available on this site.
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