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FDA BLA · BLA209196

ADMELOG

insulin lispro

Sponsor: SANOFI-AVENTIS US

APPLICATION
BLA209196
TYPE
BLA
ORIGINAL APPROVAL
2017-12-11
LATEST ACTION
2023-08-31
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ADMELOGPrescription
INSULIN LISPRO 300 UNITS/3ML (100 UNITS/ML) · SOLUTION · INTRAVENOUS, SUBCUTANEOUS
ADMELOGPrescription
INSULIN LISPRO 1000 UNITS/10ML (100 UNITS/ML) · SOLUTION · INTRAVENOUS, SUBCUTANEOUS
ADMELOG SOLOSTARPrescription
INSULIN LISPRO 300 UNITS/3ML (100 UNITS/ML) · SOLUTION · SUBCUTANEOUS

Approval history

2023-08-31Labeling · Supplement 7 · standard — Letter ↗AP
2019-11-15Labeling · Supplement 5 · 901 required — Letter ↗AP
2019-11-15Labeling · Supplement 4 · standard — Letter ↗AP
2018-11-01Labeling · Supplement 2 · standard — Letter ↗AP
2018-10-19Manufacturing (CMC) · Supplement 1AP
2017-12-11Type 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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