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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212243
Company: CIPLA 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
12/26/2024 ORIG-1 Tentative Approval STANDARD Letter (PDF)
Letter (PDF)

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 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/212243Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/212243Orig1s000TAltr.pdf
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