← FDA DRUG APPROVALS

FDA BLA · BLA021017

HUMALOG MIX75/25 KWIKPEN

insulin lispro

Sponsor: LILLY

APPLICATION
BLA021017
TYPE
BLA
ORIGINAL APPROVAL
1999-12-22
LATEST ACTION
2023-07-21
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

HUMALOG MIX 75/25 PENDiscontinued
INSULIN LISPRO PROTAMINE RECOMBINANT 75 UNITS/ML, INSULIN LISPRO RECOMBINANT 25 UNITS/ML · INJECTABLE · INJECTION
HUMALOG MIX 75/25Prescription
INSULIN LISPRO PROTAMINE RECOMBINANT 75 UNITS/ML, INSULIN LISPRO RECOMBINANT 25 UNITS/ML · INJECTABLE · INJECTION
HUMALOG MIX 75/25 KWIKPENPrescription
INSULIN LISPRO PROTAMINE RECOMBINANT 75 UNITS/ML, INSULIN LISPRO RECOMBINANT 25 UNITS/ML · INJECTABLE · INJECTION

Approval history

2023-07-21Labeling · Supplement 146 · standard — Letter ↗AP
2019-11-15Labeling · Supplement 143 · 901 required — Label ↗AP
2019-11-15Labeling · Supplement 141 · standard — Label ↗AP
2018-09-26Labeling · Supplement 79 · standard — Label ↗AP
2018-09-26Labeling · Supplement 75 · standard — Label ↗AP
2017-01-06Labeling · Supplement 122 · standard — Label ↗AP
2015-04-24Manufacturing (CMC) · Supplement 110 · standardAP
2015-02-25Labeling · Supplement 108 · 901 required — Label ↗AP
2014-09-12Manufacturing (CMC) · Supplement 103 · standardAP
2014-06-04Manufacturing (CMC) · Supplement 102 · standardAP
2014-04-11Manufacturing (CMC) · Supplement 100 · standardAP
2014-03-18Manufacturing (CMC) · Supplement 98 · standardAP
2014-03-04Manufacturing (CMC) · Supplement 97 · standardAP
2014-01-24Manufacturing (CMC) · Supplement 99 · standardAP
2013-12-12Manufacturing (CMC) · Supplement 95 · standardAP
2013-08-15Manufacturing (CMC) · Supplement 94 · standardAP
2013-06-12Manufacturing (CMC) · Supplement 86 · standardAP
2013-05-10Manufacturing (CMC) · Supplement 88 · standardAP
2013-03-28Manufacturing (CMC) · Supplement 91 · standardAP
2013-03-11Labeling · Supplement 72 · standard — Letter ↗AP
2013-02-15Manufacturing (CMC) · Supplement 87 · standardAP
2013-01-30Labeling · Supplement 82 · standard — Letter ↗AP
2012-03-21Manufacturing (CMC) · Supplement 61 · standardAP
2011-10-30Labeling · Supplement 74 · standard — Label ↗AP
2009-03-16Manufacturing (CMC) · Supplement 53 · standard — Letter ↗AP
2007-09-07Labeling · Supplement 29 · standard — Letter ↗AP
2007-09-06Manufacturing (CMC) · Supplement 40 · standard — Letter ↗AP
2007-08-22Labeling · Supplement 30 · standard — Letter ↗AP
2005-11-09Labeling · Supplement 25 · standardAP
2004-04-23Labeling · Supplement 6 · standard — Letter ↗AP
2004-04-23Labeling · Supplement 15 · standard — Letter ↗AP
2004-04-21Manufacturing (CMC) · Supplement 18 · standard — Letter ↗AP
2003-11-19Manufacturing (CMC) · Supplement 13 · standard — Letter ↗AP
2003-06-30Labeling · Supplement 10 · standard — Letter ↗AP
2002-10-25Manufacturing (CMC) · Supplement 4 · standardAP
2002-04-05Manufacturing (CMC) · Supplement 3 · standardAP
2002-02-08Labeling · Supplement 2 · standard — Review ↗AP
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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