← FDA DRUG APPROVALS

FDA BLA · BLA761215

REZVOGLAR KWIKPEN

insulin glargine-aglr

Sponsor: ELI LILLY CO

APPLICATION
BLA761215
TYPE
BLA
ORIGINAL APPROVAL
2021-12-17
LATEST ACTION
2024-08-09
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

REZVOGLARPrescription
INSULIN GLARGINE-AGLR 3ML(100UNITS/ML) · INJECTABLE · INJECTION

Approval history

2024-08-09Labeling · Supplement 5 · standard — Label ↗AP
2022-11-16Type 2 - New Active Ingredient · Original · standard — Label ↗AP
2021-12-17Type 2 - New Active Ingredient · 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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