← FDA DRUG APPROVALS

FDA BLA · BLA205747

HUMALOG KWIKPEN

insulin lispro

Sponsor: ELI LILLY AND CO

APPLICATION
BLA205747
TYPE
BLA
ORIGINAL APPROVAL
2015-05-26
LATEST ACTION
2025-05-07
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

HUMALOG KWIKPENPrescription
INSULIN LISPRO RECOMBINANT 200 UNITS/ML · SOLUTION · SUBCUTANEOUS

Approval history

2025-05-07Labeling · Supplement 38 · standard — Letter ↗AP
2023-07-21Labeling · Supplement 28 · standard — Letter ↗AP
2019-11-15Labeling · Supplement 26 · 901 required — Letter ↗AP
2019-11-15Labeling · Supplement 22 · standard — Letter ↗AP
2019-11-15Labeling · Supplement 25 · standard — Letter ↗AP
2019-08-13Labeling · Supplement 21 · standard — Label ↗AP
2018-11-01Labeling · Supplement 18 · standard — Letter ↗AP
2017-06-06Labeling · Supplement 10 · standard — Letter ↗AP
2017-01-06Labeling · Supplement 8 · standard — Letter ↗AP
2016-08-05Manufacturing (CMC) · Supplement 6 · standardAP
2015-11-25Manufacturing (CMC) · Supplement 1 · standardAP
2015-05-26Type 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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