← FDA DRUG APPROVALS

FDA BLA · BLA018780

HUMULIN R

insulin human

Sponsor: LILLY

APPLICATION
BLA018780
TYPE
BLA
ORIGINAL APPROVAL
1982-10-28
LATEST ACTION
2022-06-27
ROUTE
PARENTERAL, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE, SOLUTION
MARKETING STATUS
Over-the-counter, Prescription

Products

HUMULIN R PENOver-the-counter
INSULIN RECOMBINANT HUMAN 100 UNITS/ML · INJECTABLE · INJECTION
HUMULIN ROver-the-counter
INSULIN RECOMBINANT HUMAN 100 UNITS/ML · INJECTABLE · INJECTION
HUMULIN RPrescription
INSULIN HUMAN 10000 UNITS/20ML (500 UNITS/ML) · SOLUTION · SUBCUTANEOUS
HUMULIN R KWIKPENPrescription
INSULIN HUMAN 1500 UNITS/3ML (500 UNITS/ML) · SOLUTION · SUBCUTANEOUS

Approval history

2022-06-27Labeling · Supplement 180 · standard — Letter ↗AP
2019-11-15Labeling · Supplement 176 · 901 required — Label ↗AP
2019-11-15Labeling · Supplement 175 · standard — Letter ↗AP
2019-08-22Labeling · Supplement 172 · standard — Label ↗AP
2018-11-06Labeling · Supplement 168 · standard — Letter ↗AP
2018-05-25Labeling · Supplement 134 · standard — Other ↗AP
2018-05-25Manufacturing (CMC) · Supplement 126 · standard — Letter ↗AP
2016-07-08Labeling · Supplement 153 · standard — Letter ↗AP
2016-06-24Manufacturing (CMC) · Supplement 155 · standardAP
2016-02-26Manufacturing (CMC) · Supplement 154 · standardAP
2015-12-29Labeling · Supplement 152 · standard — Label ↗AP
2015-12-29Labeling · Supplement 135 · standard — Letter ↗AP
2015-10-08Manufacturing (CMC) · Supplement 151 · standardAP
2015-02-25Labeling · Supplement 150 · 901 required — Label ↗AP
2014-10-30Manufacturing (CMC) · Supplement 149 · standardAP
2014-09-23Manufacturing (CMC) · Supplement 148 · standard — Label ↗AP
2014-06-20Manufacturing (CMC) · Supplement 147 · standardAP
2014-03-18Manufacturing (CMC) · Supplement 146 · standardAP
2013-08-15Manufacturing (CMC) · Supplement 145 · standardAP
2013-05-31Manufacturing (CMC) · Supplement 144 · standardAP
2013-05-30Manufacturing (CMC) · Supplement 143 · standardAP
2013-05-10Manufacturing (CMC) · Supplement 142 · standardAP
2013-03-09Labeling · Supplement 132 · standard — Label ↗AP
2013-01-09Manufacturing (CMC) · Supplement 139 · standardAP
2012-11-07Manufacturing (CMC) · Supplement 141 · standardAP
2012-03-29Manufacturing (CMC) · Supplement 127 · standardAP
2011-10-30Labeling · Supplement 133 · standard — Letter ↗AP
2011-03-25Efficacy · Supplement 120 · standard — Label ↗AP
2011-03-21Labeling · Supplement 124 · standard — Other ↗AP
2010-06-10Labeling · Supplement 128 · unknown — Label ↗AP
2007-09-10Labeling · Supplement 114 · standard — Label ↗AP
2007-09-07Labeling · Supplement 94 · standard — Letter ↗AP
2007-08-22Labeling · Supplement 95 · standard — Letter ↗AP
2005-02-25Manufacturing (CMC) · Supplement 86 · standard — Label ↗AP
2003-11-10Manufacturing (CMC) · Supplement 80 · standard — Label ↗AP
2003-04-14Labeling · Supplement 66 · standard — Letter ↗AP
2003-02-10Labeling · Supplement 67 · standard — Label ↗AP
2003-02-10Manufacturing (CMC) · Supplement 78 · standard — Letter ↗AP
2002-10-25Manufacturing (CMC) · Supplement 76 · standardAP
2002-10-10Manufacturing (CMC) · Supplement 70 · standardAP
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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