← FDA DRUG APPROVALS

FDA BLA · BLA205692

BASAGLAR KWIKPEN

insulin glargine

Sponsor: ELI LILLY AND CO

APPLICATION
BLA205692
TYPE
BLA
ORIGINAL APPROVAL
2015-12-16
LATEST ACTION
2021-07-20
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

BASAGLARPrescription
INSULIN GLARGINE 300 UNITS/3ML (100 UNITS/ML) · SOLUTION · SUBCUTANEOUS

Approval history

2021-07-20Labeling · Supplement 33 · standard — Letter ↗AP
2019-11-15Labeling · Supplement 24 · standard — Letter ↗AP
2019-11-15Labeling · Supplement 25 · 901 required — Label ↗AP
2019-11-15Labeling · Supplement 21 · standard — Letter ↗AP
2018-09-05Labeling · Supplement 19 · standard — Letter ↗AP
2016-06-17Labeling · Supplement 1 · standard — Other ↗AP
2016-06-17Manufacturing (CMC) · Supplement 2 · standardAP
2016-06-01Labeling · Supplement 5 · standard — Letter ↗AP
2015-12-16Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗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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