Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208454
Company: SUN PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE LINAGLIPTIN AND METFORMIN HYDROCHLORIDE 2.5MG/500MG TABLET; ORAL Prescription None No No
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE LINAGLIPTIN AND METFORMIN HYDROCHLORIDE 2.5MG/850MG TABLET; ORAL Prescription None No No
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE LINAGLIPTIN AND METFORMIN HYDROCHLORIDE 2.5MG/1GM TABLET; ORAL Prescription 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
05/28/2020 ORIG-1 Tentative Approval STANDARD Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208454Orig1s000TAltr.pdf

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