← FDA DRUG APPROVALS

FDA NDA · NDA206073

GLYXAMBI

empagliflozin and linagliptin

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA206073
TYPE
NDA
ORIGINAL APPROVAL
2015-01-30
LATEST ACTION
2025-10-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

GLYXAMBI · ReferencePrescription
EMPAGLIFLOZIN 10MG, LINAGLIPTIN 5MG · TABLET · ORAL
GLYXAMBI · ReferencePrescription
EMPAGLIFLOZIN 25MG, LINAGLIPTIN 5MG · TABLET · ORAL

Approval history

2025-10-24Labeling · Supplement 44 · standard — Label ↗AP
2023-10-30Labeling · Supplement 36 · standard — Label ↗AP
2022-10-13Labeling · Supplement 33 · 901 required — Letter ↗AP
2022-03-21Labeling · Supplement 31 · standard — Letter ↗AP
2021-06-11Labeling · Supplement 27 · standard — Label ↗AP
2021-06-11Labeling · Supplement 30 · standard — Label ↗AP
2020-03-30Efficacy · Supplement 21 · standard — Letter ↗AP
2020-01-24Labeling · Supplement 23 · 901 required — Label ↗AP
2019-07-03Efficacy · Supplement 17 · standard — Letter ↗AP
2019-07-01Labeling · Supplement 22 · standard — Letter ↗AP
2018-10-26Labeling · Supplement 19 · 901 required — Label ↗AP
2017-12-13Labeling · Supplement 12 · standard — Label ↗AP
2017-08-10Labeling · Supplement 13 · standard — Label ↗AP
2017-08-10Labeling · Supplement 11 · standard — Label ↗AP
2017-03-14Labeling · Supplement 8 · standard — Letter ↗AP
2016-12-23Labeling · Supplement 9 · 901 required — Letter ↗AP
2016-12-23Efficacy · Supplement 7 · standard — Letter ↗AP
2016-07-08Labeling · Supplement 6 · standard — Letter ↗AP
2015-12-04Labeling · Supplement 3 · 901 required — Letter ↗AP
2015-08-28Labeling · Supplement 1 · 901 required — Label ↗AP
2015-01-30Type 4 - New Combination · Original · standard — Label ↗AP
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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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