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FDA BLA · BLA208157

MYXREDLIN

insulin human

Sponsor: BAXTER HLTHCARE CORP

APPLICATION
BLA208157
TYPE
BLA
ORIGINAL APPROVAL
2019-06-20
LATEST ACTION
2025-03-07
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

MYXREDLINPrescription
INSULIN HUMAN 100 UNITS/100ML (1 UNIT/ML) · SOLUTION · INTRAVENOUS

Approval history

2025-03-07Labeling · Supplement 8 · standard — Letter ↗AP
2020-06-04Labeling · Supplement 2 · standard — Letter ↗AP
2019-06-20Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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