← FDA DRUG APPROVALS

FDA BLA · BLA208583

XULTOPHY 100/3.6

insulin degludec and liraglutide

Sponsor: NOVO

APPLICATION
BLA208583
TYPE
BLA
ORIGINAL APPROVAL
2016-11-21
LATEST ACTION
2025-10-14
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

XULTOPHY 100/3.6Prescription
INSULIN DEGLUDEC 300 UNITS/3ML, LIRAGLUTIDE 10.8MG/3ML (100 UNITS/ML · SOLUTION · SUBCUTANEOUS

Approval history

2025-10-14Labeling · Supplement 26 · standard — Letter ↗AP
2025-05-28Labeling · Supplement 25 · standard — Letter ↗AP
2024-11-01Labeling · Supplement 24 · 901 required — Label ↗AP
2023-07-10Labeling · Supplement 21 · standard — Letter ↗AP
2022-06-10Labeling · Supplement 19 · 901 required — Letter ↗AP
2022-06-10Labeling · Supplement 18 · standard — Letter ↗AP
2019-11-15Labeling · Supplement 14 · standard — Label ↗AP
2019-11-15Labeling · Supplement 15 · 901 required — Label ↗AP
2019-08-08Efficacy · Supplement 12 · standard — Letter ↗AP
2019-02-27Efficacy · Supplement 10 · standard — Label ↗AP
2019-02-27Efficacy · Supplement 8 · standard — Letter ↗AP
2019-02-27Efficacy · Supplement 11 · standard — Label ↗AP
2019-02-01Efficacy · Supplement 3 · standard — Letter ↗AP
2019-02-01Efficacy · Supplement 2 · standard — Letter ↗AP
2017-12-12REMS · Supplement 1 — Letter ↗AP
2016-11-21Type 4 - New Combination · Original · standard — Letter ↗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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