← FDA DRUG APPROVALS

FDA BLA · BLA018781

HUMULIN N

insulin human

Sponsor: LILLY

APPLICATION
BLA018781
TYPE
BLA
ORIGINAL APPROVAL
1982-10-28
LATEST ACTION
2022-06-27
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Over-the-counter

Products

HUMULIN NOver-the-counter
INSULIN SUSP ISOPHANE RECOMBINANT HUMAN 100 UNITS/ML · INJECTABLE · INJECTION

Approval history

2022-06-27Labeling · Supplement 193 · standard — Letter ↗AP
2019-11-15Labeling · Supplement 187 · standard — Letter ↗AP
2019-11-15Labeling · Supplement 188 · 901 required — Letter ↗AP
2019-08-22Labeling · Supplement 184 · standard — Label ↗AP
2018-11-06Labeling · Supplement 181 · standard — Letter ↗AP
2017-01-06Labeling · Supplement 167 · standard — Letter ↗AP
2016-04-22Manufacturing (CMC) · Supplement 161 · standardAP
2016-04-05Manufacturing (CMC) · Supplement 163 · standardAP
2016-02-19Manufacturing (CMC) · Supplement 160 · standardAP
2015-10-20Manufacturing (CMC) · Supplement 159 · standardAP
2015-10-08Manufacturing (CMC) · Supplement 158 · standardAP
2015-07-15Manufacturing (CMC) · Supplement 157 · standardAP
2015-03-12Labeling · Supplement 156 · standard — Letter ↗AP
2015-03-03Manufacturing (CMC) · Supplement 155 · standardAP
2015-02-25Labeling · Supplement 154 · 901 required — Label ↗AP
2015-01-12Manufacturing (CMC) · Supplement 153 · standardAP
2014-09-30Manufacturing (CMC) · Supplement 120 · standard — Label ↗AP
2014-09-12Manufacturing (CMC) · Supplement 150 · standardAP
2014-06-10Manufacturing (CMC) · Supplement 146 · standardAP
2014-06-04Manufacturing (CMC) · Supplement 147 · standardAP
2014-04-11Manufacturing (CMC) · Supplement 143 · standardAP
2014-04-03Manufacturing (CMC) · Supplement 142 · standardAP
2014-03-18Manufacturing (CMC) · Supplement 140 · standardAP
2014-03-04Manufacturing (CMC) · Supplement 139 · standardAP
2014-01-24Manufacturing (CMC) · Supplement 141 · standardAP
2014-01-15Labeling · Supplement 145 · standard — Letter ↗AP
2013-12-12Manufacturing (CMC) · Supplement 137 · standardAP
2013-12-09Labeling · Supplement 144 · standard — Letter ↗AP
2013-11-07Labeling · Supplement 118 · unknown — Label ↗AP
2013-11-07Labeling · Supplement 122 · standard — Label ↗AP
2013-08-21Manufacturing (CMC) · Supplement 132 · standardAP
2013-08-15Manufacturing (CMC) · Supplement 136 · standardAP
2013-06-12Manufacturing (CMC) · Supplement 126 · standardAP
2013-05-31Manufacturing (CMC) · Supplement 134 · standardAP
2013-05-30Manufacturing (CMC) · Supplement 133 · standardAP
2013-05-10Manufacturing (CMC) · Supplement 129 · standardAP
2013-03-25Manufacturing (CMC) · Supplement 130 · standardAP
2013-03-09Labeling · Supplement 121 · unknown — Label ↗AP
2013-02-21Manufacturing (CMC) · Supplement 131 · standardAP
2013-02-15Manufacturing (CMC) · Supplement 128 · standardAP
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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