Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202293
Company: ASTRAZENECA AB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FARXIGA DAPAGLIFLOZIN 5MG TABLET;ORAL Prescription None Yes No
FARXIGA DAPAGLIFLOZIN 10MG TABLET;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
01/08/2014 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202293s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202293Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/202293Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/202293Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/26/2018 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202293s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202293Orig1s017,205649Origs010,209091Orig1s003ltr.pdf
10/20/2017 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202293s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202293Orig1s012ltr.pdf
03/01/2017 SUPPL-11 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202293s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202293Orig1s011ltr.pdf
08/17/2016 SUPPL-10 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202293s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202293Orig1s010ltr.pdf
06/14/2016 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202293s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202293Orig1s009ltr.pdf
12/04/2015 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202293s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202293Orig1s008ltr.pdf
01/06/2016 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/12/2016 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/08/2014 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202293s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202293Orig1s003ltr.pdf
03/11/2015 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202293s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202293Orig1s002ltr.pdf
07/31/2014 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
10/26/2018 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202293s017lbl.pdf
10/20/2017 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202293s012lbl.pdf
03/01/2017 SUPPL-11 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202293s011lbl.pdf
03/01/2017 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202293s011lbl.pdf
08/17/2016 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202293s010lbl.pdf
08/17/2016 SUPPL-10 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202293s010lbl.pdf
06/14/2016 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202293s009lbl.pdf
12/04/2015 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202293s008lbl.pdf
03/11/2015 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202293s002lbl.pdf
08/08/2014 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202293s003lbl.pdf
01/08/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202293s000lbl.pdf

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