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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212362
Company: MSN LABS PVT LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE 5MG/1000MG TABLET, EXTENDED RELEASE; ORAL None (Tentative Approval) None No No
EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE 10MG/1000MG TABLET, EXTENDED RELEASE; ORAL None (Tentative Approval) None No No
EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE 12.5MG/1000MG TABLET, EXTENDED RELEASE; ORAL None (Tentative Approval) None No No
EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE 25MG/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
01/31/2023 ORIG-1 Tentative Approval STANDARD Letter (PDF)

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 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212362Orig1s000TAltr.pdf
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