← FDA DRUG APPROVALS

FDA BLA · BLA021018

HUMALOG MIX50/50 KWIKPEN

insulin lispro

Sponsor: LILLY

APPLICATION
BLA021018
TYPE
BLA
ORIGINAL APPROVAL
1999-12-22
LATEST ACTION
2023-07-21
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

HUMALOG MIX 50/50 KWIKPENPrescription
INSULIN LISPRO PROTAMINE RECOMBINANT 50 UNITS/ML, INSULIN LISPRO RECOMBINANT 50 UNITS/ML · INJECTABLE · INJECTION
HUMALOG MIX 50/50 PENDiscontinued
INSULIN LISPRO PROTAMINE RECOMBINANT 50 UNITS/ML, INSULIN LISPRO RECOMBINANT 50 UNITS/ML · INJECTABLE · INJECTION
HUMALOG MIX 50/50Prescription
INSULIN LISPRO PROTAMINE RECOMBINANT 50 UNITS/ML, INSULIN LISPRO RECOMBINANT 50 UNITS/ML · INJECTABLE · INJECTION

Approval history

2023-07-21Labeling · Supplement 132 · standard — Letter ↗AP
2019-11-15Labeling · Supplement 127 · standard — Letter ↗AP
2019-11-15Labeling · Supplement 129 · 901 required — Letter ↗AP
2018-09-26Labeling · Supplement 74 · standard — Letter ↗AP
2018-09-26Labeling · Supplement 70 · standard — Letter ↗AP
2017-01-06Labeling · Supplement 111 · standard — Letter ↗AP
2015-02-25Labeling · Supplement 100 · 901 required — Label ↗AP
2014-09-12Manufacturing (CMC) · Supplement 96 · standardAP
2014-06-04Manufacturing (CMC) · Supplement 95 · standardAP
2014-04-11Manufacturing (CMC) · Supplement 93 · standardAP
2014-04-03Manufacturing (CMC) · Supplement 92 · standardAP
2014-03-18Manufacturing (CMC) · Supplement 90 · standardAP
2014-01-24Manufacturing (CMC) · Supplement 91 · standardAP
2013-08-15Manufacturing (CMC) · Supplement 88 · standardAP
2013-03-28Manufacturing (CMC) · Supplement 85 · standardAP
2013-03-11Labeling · Supplement 67 · standard — Label ↗AP
2013-02-15Manufacturing (CMC) · Supplement 81 · standardAP
2013-01-30Labeling · Supplement 77 · standard — Label ↗AP
2012-03-21Manufacturing (CMC) · Supplement 56 · standardAP
2011-10-30Labeling · Supplement 69 · standard — Label ↗AP
2009-03-16Manufacturing (CMC) · Supplement 49 · standard — Letter ↗AP
2008-05-01Labeling · Supplement 35 · standard — Letter ↗AP
2007-09-07Labeling · Supplement 23 · standard — Letter ↗AP
2007-09-06Manufacturing (CMC) · Supplement 34 · standard — Label ↗AP
2007-08-22Labeling · Supplement 41 · standard — Label ↗AP
2003-11-19Manufacturing (CMC) · Supplement 11 · standard — Label ↗AP
2002-10-25Manufacturing (CMC) · Supplement 4 · standardAP
2002-04-05Manufacturing (CMC) · Supplement 3 · standardAP
2002-03-21Manufacturing (CMC) · Supplement 2 · standardAP
2002-02-08Labeling · Supplement 1 · standardAP
1999-12-22Type 3 - New Dosage Form and Type 4 - New Combination · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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