← FDA DRUG APPROVALS

FDA NDA · NDA201281

JENTADUETO

linagliptin and metformin hydrochloride

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA201281
TYPE
NDA
ORIGINAL APPROVAL
2012-01-30
LATEST ACTION
2023-06-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

JENTADUETO · ReferencePrescription
LINAGLIPTIN 2.5MG, METFORMIN HYDROCHLORIDE 850MG · TABLET · ORAL
JENTADUETO · ReferencePrescription
LINAGLIPTIN 2.5MG, METFORMIN HYDROCHLORIDE 1GM · TABLET · ORAL
JENTADUETO · ReferencePrescription
LINAGLIPTIN 2.5MG, METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL

Approval history

2023-06-20Efficacy · Supplement 35 · priority — Letter ↗AP
2022-04-15Labeling · Supplement 31 · standard — Letter ↗AP
2020-03-30Efficacy · Supplement 24 · standard — Letter ↗AP
2019-07-03Efficacy · Supplement 22 · standard — Letter ↗AP
2019-07-01Labeling · Supplement 25 · 901 required — Letter ↗AP
2017-08-10Labeling · Supplement 19 · standard — Label ↗AP
2017-03-14Labeling · Supplement 17 · standard — Letter ↗AP
2016-12-23Labeling · Supplement 18 · standard — Label ↗AP
2016-12-23Labeling · Supplement 14 · 901 required — Label ↗AP
2016-04-29Manufacturing (CMC) · Supplement 12 · standardAP
2016-02-11Manufacturing (CMC) · Supplement 11 · standardAP
2015-09-18Manufacturing (CMC) · Supplement 9 · standardAP
2015-08-28Labeling · Supplement 10 · 901 required — Label ↗AP
2015-07-28Labeling · Supplement 8 · standard — Label ↗AP
2014-07-30Efficacy · Supplement 6 · standard — Label ↗AP
2014-05-22Labeling · Supplement 7 · standard — Label ↗AP
2013-12-18Manufacturing (CMC) · Supplement 5 · standardAP
2013-09-05Efficacy · Supplement 4 · standard — Label ↗AP
2013-06-18Labeling · Supplement 3 · unknown — Label ↗AP
2012-09-25Labeling · Supplement 2 · unknown — Letter ↗AP
2012-01-30Type 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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