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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208658
Company: BOEHRINGER INGELHEIM

Medication Guide

Products on NDA 208658

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SYNJARDY XR	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	5MG;1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
SYNJARDY XR	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	10MG;1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
SYNJARDY XR	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	12.5MG;1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
SYNJARDY XR	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	25MG;1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208658

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/09/2016	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208658s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208658Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208658Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/30/2023	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s042,208658s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206073Orig1s036; 206111Orig1s042; 208658Orig1s028; 212614Orig1s020ltr.pdf
06/20/2023	SUPPL-26	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s038s039,208658s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206111Orig1s038,s039;208658Orig1s025,s026ltr.pdf
06/20/2023	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s038s039,208658s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206111Orig1s038,s039;208658Orig1s025,s026ltr.pdf
10/13/2022	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208658s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204629Orig1s039,206073Orig1s033,206111Orig1s036,208658Orig1s023ltr.pdf
02/06/2023	SUPPL-21	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208658s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206111Orig1s033,208658Orig1s021ltr.pdf
03/21/2022	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208658s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204629Orig1s034;206073Orig1s031;206111Orig1s031;208658Orig1s017ltr.pdf
06/11/2021	SUPPL-15	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208658s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204629Orig1s028, s029; 206073Orig1s027, s030; 206111Orig1s025, s026; 208658Orig1s013, s015; 212614Orig1s008, s010ltr.pdf
06/11/2021	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208658s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204629Orig1s028, 206073Orig1s027, 206111Orig1s025, 208658Orig1s013, 212614Orig1s008ltr.pdf
01/24/2020	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208658s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204629Orig1s023,206073Orig1s023,206111Orig1s022,208658Orig1s009ltr.pdf
10/26/2018	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208658s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204629Orig1s018,206073Orig1s019,206111Orig1s018,208658Orig1s006ltr.pdf
12/13/2017	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208658s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206111Orig1s015,208658Orig1s004ltr.pdf
12/23/2016	SUPPL-1	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208658s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208658Orig1s001ltr.pdf

Labels for NDA 208658

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/30/2023	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s042,208658s028lbl.pdf
06/20/2023	SUPPL-26	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s038s039,208658s025s026lbl.pdf
06/20/2023	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s038s039,208658s025s026lbl.pdf
02/06/2023	SUPPL-21	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208658s021lbl.pdf
10/13/2022	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208658s023lbl.pdf
03/21/2022	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208658s017lbl.pdf
06/11/2021	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208658s013s015lbl.pdf
06/11/2021	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208658s013s015lbl.pdf
01/24/2020	SUPPL-9	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208658s009lbl.pdf
01/24/2020	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208658s009lbl.pdf
10/26/2018	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208658s006lbl.pdf
10/26/2018	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208658s006lbl.pdf
12/13/2017	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208658s004lbl.pdf
12/23/2016	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208658s001lbl.pdf
12/09/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208658s000lbl.pdf

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