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FDA BLA · BLA206538

TOUJEO

insulin glargine

Sponsor: SANOFI US SERVICES

APPLICATION
BLA206538
TYPE
BLA
ORIGINAL APPROVAL
2015-02-25
LATEST ACTION
2024-08-29
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

TOUJEO SOLOSTARPrescription
INSULIN GLARGINE RECOMBINANT 450 UNITS/1.5ML (300 UNITS/ML) · SOLUTION · SUBCUTANEOUS
TOUJEO MAX SOLOSTARPrescription
INSULIN GLARGINE RECOMBINANT 900 UNITS/3ML (300 UNITS/ML) · SOLUTION · SUBCUTANEOUS

Approval history

2024-08-29Labeling · Supplement 17 · standard — Label ↗AP
2022-08-16Labeling · Supplement 16 · standard — Letter ↗AP
2019-11-26Efficacy · Supplement 12 · standard — Label ↗AP
2019-11-15Labeling · Supplement 14 · standard — Letter ↗AP
2019-11-15Labeling · Supplement 13 · standard — Label ↗AP
2018-10-25Labeling · Supplement 10 · standard — Label ↗AP
2018-10-25Manufacturing (CMC) · Supplement 11 — Label ↗AP
2018-03-26Labeling · Supplement 6 · standard — Letter ↗AP
2016-11-23Manufacturing (CMC) · Supplement 3 · standardAP
2016-02-16Manufacturing (CMC) · Supplement 2 · standardAP
2015-09-29Manufacturing (CMC) · Supplement 1 · standard — Letter ↗AP
2015-02-25Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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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