Documents
Application Sponsors
| BLA 021629 | SANOFI AVENTIS US | |
Marketing Status
| Prescription | 001 |
| Discontinued | 002 |
| Prescription | 003 |
Application Products
| 001 | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 1000 UNITS/10ML (100 UNITS/ML) | 0 | APIDRA | INSULIN GLULISINE RECOMBINANT |
| 002 | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | 0 | APIDRA | INSULIN GLULISINE RECOMBINANT |
| 003 | INJECTABLE;SUBCUTANEOUS | 300 UNITS/3ML | 0 | APIDRA SOLOSTAR | INSULIN GLULISINE RECOMBINANT |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2004-04-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2005-12-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2009-02-24 | N/A |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 2007-04-12 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 15 | AP | 2008-10-24 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2013-07-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 2013-06-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2013-02-15 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2013-09-06 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2014-05-14 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2015-02-25 | 901 REQUIRED |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2015-03-03 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2018-12-20 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2018-12-20 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2019-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2019-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2022-11-30 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 15 |
| SUPPL | 29 | Null | 6 |
| SUPPL | 30 | Null | 6 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 37 | Null | 7 |
| SUPPL | 38 | Null | 31 |
| SUPPL | 39 | Null | 15 |
| SUPPL | 40 | Null | 6 |
| SUPPL | 42 | Null | 6 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 21629
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"APIDRA","activeIngredients":"INSULIN GLULISINE RECOMBINANT","strength":"1000 UNITS\/10ML (100 UNITS\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"APIDRA","activeIngredients":"INSULIN GLULISINE RECOMBINANT","strength":"300 UNITS\/3ML (100 UNITS\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"APIDRA SOLOSTAR","activeIngredients":"INSULIN GLULISINE RECOMBINANT","strength":"300 UNITS\/3ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"04\/16\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/021629lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"APIDRA","submission":"INSULIN GLULISINE RECOMBINANT","actionType":"1000 UNITS\/10ML (100 UNITS\/ML)","submissionClassification":"INJECTABLE;INTRAVENOUS, SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"APIDRA","submission":"INSULIN GLULISINE RECOMBINANT","actionType":"300 UNITS\/3ML (100 UNITS\/ML)","submissionClassification":"INJECTABLE;INTRAVENOUS, SUBCUTANEOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"APIDRA SOLOSTAR","submission":"INSULIN GLULISINE RECOMBINANT","actionType":"300 UNITS\/3ML","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2004-04-16
)
)