← FDA DRUG APPROVALS

FDA NDA · NDA208026

JENTADUETO XR

linagliptin and metformin hydrochloride

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA208026
TYPE
NDA
ORIGINAL APPROVAL
2016-05-27
LATEST ACTION
2023-06-20
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

JENTADUETO XR · ReferencePrescription
LINAGLIPTIN 5MG, METFORMIN HYDROCHLORIDE 1GM · TABLET, EXTENDED RELEASE · ORAL
JENTADUETO XR · ReferencePrescription
LINAGLIPTIN 2.5MG, METFORMIN HYDROCHLORIDE 1GM · TABLET, EXTENDED RELEASE · ORAL

Approval history

2023-06-20Efficacy · Supplement 24 · priority — Letter ↗AP
2021-10-01Labeling · Supplement 20 · standard — Label ↗AP
2020-03-30Efficacy · Supplement 12 · standard — Letter ↗AP
2019-07-03Efficacy · Supplement 8 · standard — Letter ↗AP
2019-07-01Labeling · Supplement 13 · 901 required — Letter ↗AP
2017-08-10Labeling · Supplement 5 · standard — Label ↗AP
2017-03-14Labeling · Supplement 3 · standard — Letter ↗AP
2016-12-23Labeling · Supplement 4 · standard — Label ↗AP
2016-05-27Type 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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