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FDA NDA · NDA206111

SYNJARDY

empagliflozin and metformin hydrochloride

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA206111
TYPE
NDA
ORIGINAL APPROVAL
2015-08-26
LATEST ACTION
2025-10-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SYNJARDY · ReferencePrescription
EMPAGLIFLOZIN 12.5MG, METFORMIN HYDROCHLORIDE 1GM · TABLET · ORAL
SYNJARDY · ReferencePrescription
EMPAGLIFLOZIN 5MG, METFORMIN HYDROCHLORIDE 1GM · TABLET · ORAL
SYNJARDY · ReferencePrescription
EMPAGLIFLOZIN 12.5MG, METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
SYNJARDY · ReferencePrescription
EMPAGLIFLOZIN 5MG, METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL

Approval history

2025-10-24Labeling · Supplement 46 · standard — Label ↗AP
2025-03-07Efficacy · Supplement 45 · standard — Letter ↗AP
2023-10-30Labeling · Supplement 42 · standard — Label ↗AP
2023-06-20Efficacy · Supplement 38 · priority — Letter ↗AP
2023-06-20Labeling · Supplement 39 · standard — Label ↗AP
2023-02-06Efficacy · Supplement 33 · standard — Letter ↗AP
2022-10-13Labeling · Supplement 36 · 901 required — Letter ↗AP
2022-03-21Labeling · Supplement 31 · standard — Letter ↗AP
2021-06-11Labeling · Supplement 25 · standard — Label ↗AP
2021-06-11Labeling · Supplement 26 · standard — Label ↗AP
2020-01-24Labeling · Supplement 22 · 901 required — Label ↗AP
2018-10-26Labeling · Supplement 18 · 901 required — Label ↗AP
2017-12-13Labeling · Supplement 15 · standard — Label ↗AP
2016-12-23Efficacy · Supplement 4 · standard — Label ↗AP
2016-07-08Labeling · Supplement 9 · 901 required — Letter ↗AP
2016-07-08Efficacy · Supplement 1 · standard — Label ↗AP
2016-07-08Labeling · Supplement 6 · standard — Letter ↗AP
2016-05-06Manufacturing (CMC) · Supplement 8 · standardAP
2015-12-04Labeling · Supplement 2 · 901 required — Label ↗AP
2015-08-26Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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