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FDA NDA · NDA022341

LIRAGLUTIDE

Sponsor: NOVO NORDISK INC

APPLICATION
NDA022341
TYPE
NDA
ORIGINAL APPROVAL
2010-01-25
LATEST ACTION
2025-10-14
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

VICTOZA · ReferencePrescription
LIRAGLUTIDE 18MG/3ML (6MG/ML) · SOLUTION · SUBCUTANEOUS

Approval history

2025-10-14Labeling · Supplement 46 · standard — Letter ↗AP
2025-05-28Labeling · Supplement 44 · standard — Label ↗AP
2025-02-12Labeling · Supplement 42 · standard — Letter ↗AP
2024-11-01Labeling · Supplement 43 · 901 required — Label ↗AP
2023-07-05Labeling · Supplement 39 · standard — Label ↗AP
2022-06-10Labeling · Supplement 37 · standard — Letter ↗AP
2022-06-10Labeling · Supplement 38 · 901 required — Letter ↗AP
2020-11-20Labeling · Supplement 36 · standard — Letter ↗AP
2020-08-05Labeling · Supplement 35 · standard — Label ↗AP
2019-06-17Efficacy · Supplement 31 · priority — Letter ↗AP
2017-08-25Efficacy · Supplement 27 · standard — Letter ↗AP
2017-07-26REMS · Supplement 29 — Letter ↗AP
2017-04-25Labeling · Supplement 28 · standard — Label ↗AP
2016-09-20REMS · Supplement 26 — Letter ↗AP
2016-04-22Efficacy · Supplement 25 · standard — Letter ↗AP
2015-07-01REMS · Supplement 24 — Letter ↗AP
2015-03-09Labeling · Supplement 23 · 901 required — Letter ↗AP
2015-02-25Labeling · Supplement 22 · 901 required — Label ↗AP
2014-07-31REMS · Supplement 21 — Letter ↗AP
2013-06-13Labeling · Supplement 20 · standard — Label ↗AP
2013-04-16Labeling · Supplement 18 · standard — Label ↗AP
2012-12-13Labeling · Supplement 17 · standard — Label ↗AP
2012-12-03Manufacturing (CMC) · Supplement 10 · standardAP
2012-04-06Efficacy · Supplement 9 · standard — Label ↗AP
2012-04-06Efficacy · Supplement 7 · standard — Label ↗AP
2012-04-06Labeling · Supplement 13 · standard — Label ↗AP
2011-05-18Labeling · Supplement 4 · standard — Label ↗AP
2010-12-22Efficacy · Supplement 1 · standard — Label ↗AP
2010-01-25Type 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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