Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Discontinued | 003 |
Application Products
| 001 | INJECTABLE;INJECTION | 75 UNITS/ML;25 UNITS/ML | 0 | HUMALOG MIX 75/25 | INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT |
| 002 | INJECTABLE;INJECTION | 75 UNITS/ML;25 UNITS/ML | 0 | HUMALOG MIX 75/25 KWIKPEN | INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT |
| 003 | INJECTABLE;INJECTION | 75 UNITS/ML;25 UNITS/ML | 0 | HUMALOG MIX 75/25 PEN | INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT |
FDA Submissions
| TYPE 3/4; Type 3 - New Dosage Form and Type 4 - New Combination | ORIG | 1 | AP | 1999-12-22 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2002-02-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2002-04-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2002-10-25 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2004-04-23 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2003-06-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2003-11-19 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2004-04-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2004-04-21 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2005-11-09 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2007-09-07 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2007-08-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 2007-09-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 53 | AP | 2009-03-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 61 | AP | 2012-03-21 | STANDARD |
| LABELING; Labeling | SUPPL | 72 | AP | 2013-03-11 | STANDARD |
| LABELING; Labeling | SUPPL | 74 | AP | 2011-10-30 | STANDARD |
| LABELING; Labeling | SUPPL | 75 | AP | 2018-09-26 | STANDARD |
| LABELING; Labeling | SUPPL | 79 | AP | 2018-09-26 | STANDARD |
| LABELING; Labeling | SUPPL | 82 | AP | 2013-01-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 86 | AP | 2013-06-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 87 | AP | 2013-02-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 88 | AP | 2013-05-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 91 | AP | 2013-03-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 94 | AP | 2013-08-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 95 | AP | 2013-12-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 97 | AP | 2014-03-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 98 | AP | 2014-03-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 99 | AP | 2014-01-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 100 | AP | 2014-04-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 102 | AP | 2014-06-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 103 | AP | 2014-09-12 | STANDARD |
| LABELING; Labeling | SUPPL | 108 | AP | 2015-02-25 | 901 REQUIRED |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 110 | AP | 2015-04-24 | STANDARD |
| LABELING; Labeling | SUPPL | 122 | AP | 2017-01-06 | STANDARD |
| LABELING; Labeling | SUPPL | 141 | AP | 2019-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 143 | AP | 2019-11-15 | 901 REQUIRED |
Submissions Property Types
| ORIG | 1 | Null | 33 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 53 | Null | 0 |
| SUPPL | 61 | Null | 0 |
| SUPPL | 72 | Null | 15 |
| SUPPL | 74 | Null | 6 |
| SUPPL | 75 | Null | 6 |
| SUPPL | 79 | Null | 6 |
| SUPPL | 82 | Null | 6 |
| SUPPL | 86 | Null | 0 |
| SUPPL | 87 | Null | 0 |
| SUPPL | 88 | Null | 0 |
| SUPPL | 91 | Null | 0 |
| SUPPL | 94 | Null | 0 |
| SUPPL | 95 | Null | 0 |
| SUPPL | 97 | Null | 0 |
| SUPPL | 98 | Null | 0 |
| SUPPL | 99 | Null | 0 |
| SUPPL | 100 | Null | 0 |
| SUPPL | 102 | Null | 0 |
| SUPPL | 103 | Null | 0 |
| SUPPL | 108 | Null | 15 |
| SUPPL | 110 | Null | 0 |
| SUPPL | 122 | Null | 7 |
| SUPPL | 141 | Null | 6 |
| SUPPL | 143 | Null | 31 |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 21017
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)