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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205649
Company: ASTRAZENECA AB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XIGDUO XR DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
XIGDUO XR DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
XIGDUO XR DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
XIGDUO XR DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription None Yes Yes
XIGDUO XR DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 2.5MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription None Yes 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
10/29/2014 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205649s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205649Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205649Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205649Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/12/2023 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205649s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202293Orig1s030;205649Orig1s021ltr.pdf
10/13/2022 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205649s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/202293Orig1s028,205649Orig1s018ltr.pdf
04/11/2022 SUPPL-17 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205649s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205649Orig1s017ltr.pdf
02/03/2022 SUPPL-16 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205649s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205649Orig1s016ltr.pdf
02/03/2020 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205649s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202293Orig1s022, 205649Orig1s014ltr.pdf
01/24/2020 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205649s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202293Orig1s021, 205649Orig1s013, 209091Orig1s005, 210874Orig1s003ltr.pdf
08/12/2019 SUPPL-12 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205649Orig1s012ltr.pdf
10/18/2019 SUPPL-11 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205649s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202293Orig1s018, 205649Orig1s011ltr.pdf
10/26/2018 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205649s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202293Orig1s017,205649Origs010,209091Orig1s003ltr.pdf
02/22/2019 SUPPL-9 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205649s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202293Orig1s015, 205649Orig1s009ltr.pdf
07/28/2017 SUPPL-8 Manufacturing (CMC)-New Strength Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205649s008lbl.pdf
01/10/2017 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/01/2017 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205649s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205649Orig1s006ltr.pdf
08/17/2016 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205649s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205649Orig1s005ltr.pdf
06/14/2016 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205649s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205649Orig1s004ltr.pdf
12/04/2015 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205649s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205649Orig1s003ltr.pdf
01/12/2016 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/01/2015 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/12/2023 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205649s021lbl.pdf
10/13/2022 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205649s018lbl.pdf
04/11/2022 SUPPL-17 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205649s017lbl.pdf
02/03/2022 SUPPL-16 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205649s016lbl.pdf
02/03/2020 SUPPL-14 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205649s014lbl.pdf
02/03/2020 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205649s014lbl.pdf
01/24/2020 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205649s013lbl.pdf
10/18/2019 SUPPL-11 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205649s011lbl.pdf
02/22/2019 SUPPL-9 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205649s009lbl.pdf
10/26/2018 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205649s010lbl.pdf
07/28/2017 SUPPL-8 Manufacturing (CMC)-New Strength Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205649s008lbl.pdf
03/01/2017 SUPPL-6 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205649s006lbl.pdf
03/01/2017 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205649s006lbl.pdf
08/17/2016 SUPPL-5 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205649s005lbl.pdf
08/17/2016 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205649s005lbl.pdf
06/14/2016 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205649s004lbl.pdf
12/04/2015 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205649s003lbl.pdf
10/29/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205649s000lbl.pdf
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