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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205649
Company: ASTRAZENECA AB

Medication Guide

Summary Review

Products on NDA 205649

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205649

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-Package Insert, Labeling-Medication Guide	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-Package Insert, Labeling-Medication Guide	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.

Labels for NDA 205649

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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205649s006lbl.pdf
03/01/2017	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205649s006lbl.pdf
08/17/2016	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205649s005lbl.pdf
08/17/2016	SUPPL-5	Labeling-Medication Guide	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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