← FDA DRUG APPROVALS

FDA NDA · NDA201280

TRADJENTA

linagliptin

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA201280
TYPE
NDA
ORIGINAL APPROVAL
2011-05-02
LATEST ACTION
2023-06-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TRADJENTA · ReferencePrescription
LINAGLIPTIN 5MG · TABLET · ORAL

Approval history

2023-06-20Efficacy · Supplement 27 · priority — Letter ↗AP
2022-04-15Labeling · Supplement 25 · standard — Letter ↗AP
2020-03-30Efficacy · Supplement 20 · standard — Letter ↗AP
2019-07-03Efficacy · Supplement 18 · standard — Letter ↗AP
2019-07-01Labeling · Supplement 21 · 901 required — Letter ↗AP
2017-08-10Labeling · Supplement 16 · standard — Label ↗AP
2017-03-14Labeling · Supplement 14 · standard — Letter ↗AP
2016-12-23Labeling · Supplement 15 · standard — Letter ↗AP
2016-12-20Manufacturing (CMC) · Supplement 13 · standardAP
2015-08-28Labeling · Supplement 12 · 901 required — Label ↗AP
2015-07-28Labeling · Supplement 11 · standard — Label ↗AP
2015-07-20Manufacturing (CMC) · Supplement 10 · standardAP
2014-05-22Labeling · Supplement 9 · standard — Label ↗AP
2013-06-18Labeling · Supplement 6 · unknown — Letter ↗AP
2012-09-28Efficacy · Supplement 5 · standard — Letter ↗AP
2012-08-13Efficacy · Supplement 4 · standard — Letter ↗AP
2012-08-13Efficacy · Supplement 3 · standard — Label ↗AP
2012-05-22Efficacy · Supplement 2 · standard — Review ↗AP
2011-05-02Type 1 - New Molecular Entity · Original · standard — Review ↗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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