APPLICATION
BLA019717
TYPE
BLA
ORIGINAL APPROVAL
1989-04-25
LATEST ACTION
2022-06-27
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Over-the-counter
Products
HUMULIN 70/30 PENOver-the-counter
INSULIN RECOMBINANT HUMAN 30 UNITS/ML, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN 70 UNITS/ML · INJECTABLE · INJECTION
HUMULIN 70/30Over-the-counter
INSULIN RECOMBINANT HUMAN 30 UNITS/ML, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN 70 UNITS/ML · INJECTABLE · INJECTION
Approval history
2014-09-12Manufacturing (CMC) · Supplement 129 · standardAP
2014-06-04Manufacturing (CMC) · Supplement 126 · standardAP
2014-04-11Manufacturing (CMC) · Supplement 122 · standardAP
2014-04-03Manufacturing (CMC) · Supplement 121 · standardAP
2014-03-18Manufacturing (CMC) · Supplement 119 · standardAP
2014-03-04Manufacturing (CMC) · Supplement 118 · standardAP
2014-01-24Manufacturing (CMC) · Supplement 120 · standardAP
2013-12-12Manufacturing (CMC) · Supplement 116 · standardAP
2013-08-21Manufacturing (CMC) · Supplement 111 · standardAP
2013-08-15Manufacturing (CMC) · Supplement 115 · standardAP
2013-06-12Manufacturing (CMC) · Supplement 105 · standardAP
2013-05-31Manufacturing (CMC) · Supplement 113 · standardAP
2013-05-30Manufacturing (CMC) · Supplement 112 · standardAP
2013-05-10Manufacturing (CMC) · Supplement 108 · standardAP
2013-02-15Manufacturing (CMC) · Supplement 107 · standardAP
2012-03-21Manufacturing (CMC) · Supplement 93 · standardAP
2005-11-09Labeling · Supplement 65 · standardAP
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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