← FDA DRUG APPROVALS

FDA BLA · BLA761201

INSULIN GLARGINE

insulin glargine-yfgn

Sponsor: MYLAN PHARMS INC

APPLICATION
BLA761201
TYPE
BLA
ORIGINAL APPROVAL
2021-07-28
LATEST ACTION
2024-11-25
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

SEMGLEEPrescription
INSULIN GLARGINE-YFGN 3ML(100UNITS/ML) · INJECTABLE · INJECTION
SEMGLEEPrescription
INSULIN GLARGINE-YFGN 10ML(100UNITS/ML) · INJECTABLE · INJECTION

Approval history

2024-11-25Labeling · Supplement 10 · standard — Label ↗AP
2023-11-29Labeling · Supplement 8 · standard — Letter ↗AP
2023-05-30Labeling · Supplement 7 · standard — Label ↗AP
2021-07-28Type 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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