Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204144
Company: ANCHEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE 500MG; EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL None (Tentative Approval) None No No
METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE 1GM; EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL None (Tentative Approval) None No No
METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE 1GM; EQ 100MG BASE 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
04/21/2015 ORIG-1 Tentative Approval

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