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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211921
Company: SUN PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LINAGLIPTIN;METFORMIN HYDROCHLORIDE LINAGLIPTIN;METFORMIN HYDROCHLORIDE 2.5MG;1000MG TABLET, EXTENDED RELEASE; ORAL None (Tentative Approval) None No No
LINAGLIPTIN;METFORMIN HYDROCHLORIDE LINAGLIPTIN;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
05/10/2023 ORIG-1 Tentative Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211921Orig1s000TA_ltr.pdf
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