Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 210874
Company: ASTRAZENECA AB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QTERNMET XR DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE 2.5MG;1GM;EQ 2.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
QTERNMET XR DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE 5MG;1GM;EQ 2.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
QTERNMET XR DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE 5MG;1GM;EQ 5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
QTERNMET XR DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE 10MG;1GM;EQ 5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/02/2019 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210874s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210874Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/01/2019 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210874s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022350Orig1s023, 200678Orig1s024, 209091Orig1s004, 210874Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/01/2019 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210874s001lbl.pdf
05/02/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210874s000lbl.pdf

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