← FDA DRUG APPROVALS

FDA BLA · BLA203314

TRESIBA

insulin degludec

Sponsor: NOVO

APPLICATION
BLA203314
TYPE
BLA
ORIGINAL APPROVAL
2015-09-25
LATEST ACTION
2022-07-01
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

TRESIBAPrescription
INSULIN DEGLUDEC 300 UNITS/3ML (100 UNITS/ML) · SOLUTION · SUBCUTANEOUS
TRESIBAPrescription
INSULIN DEGLUDEC 600 UNITS/3ML (200 UNITS/ML) · SOLUTION · SUBCUTANEOUS
TRESIBAPrescription
INSULIN DEGLUDEC 1000 UNITS/10ML (100 UNITS/ML) · SOLUTION · SUBCUTANEOUS

Approval history

2022-07-01Labeling · Supplement 18 · standard — Letter ↗AP
2022-07-01Efficacy · Supplement 20 · standard — Letter ↗AP
2019-11-15Labeling · Supplement 16 · 901 required — Letter ↗AP
2019-11-15Labeling · Supplement 15 · standard — Label ↗AP
2018-11-21Labeling · Supplement 10 · standard — Letter ↗AP
2018-08-09Efficacy · Supplement 9 · standard — Letter ↗AP
2018-03-26Efficacy · Supplement 8 · standard — Letter ↗AP
2016-12-16Efficacy · Supplement 3 · standard — Letter ↗AP
2016-07-08Manufacturing (CMC) · Supplement 2 · standardAP
2016-06-24Manufacturing (CMC) · Supplement 4 · standardAP
2015-09-25Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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