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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211583
Company: TEVA PHARMS USA INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE 2.5MG/1000MG TABLET, EXTENDED RELEASE;ORAL None (Tentative Approval) None No No
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE 5MG/500MG TABLET, EXTENDED RELEASE;ORAL None (Tentative Approval) None No No
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE 5MG/1000MG TABLET, EXTENDED RELEASE;ORAL None (Tentative Approval) None No No
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE 10MG/500MG TABLET, EXTENDED RELEASE;ORAL None (Tentative Approval) None No No
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE 10MG/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
08/03/2022 ORIG-1 Tentative Approval STANDARD Letter (PDF)

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 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211583Orig1s000TA_ltr.pdf
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