Documents
Application Sponsors
| NDA 021081 | SANOFI AVENTIS US | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 100 UNITS/ML | 1 | LANTUS | INSULIN GLARGINE RECOMBINANT |
| 002 | INJECTABLE;INJECTION | 300 UNITS/3ML (100 UNITS/ML) | 1 | LANTUS SOLOSTAR | INSULIN GLARGINE RECOMBINANT |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2000-04-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2001-03-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2001-01-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2002-08-15 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2003-05-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2004-08-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2005-02-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2005-03-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2007-04-25 | N/A |
| EFFICACY; Efficacy | SUPPL | 34 | AP | 2009-09-09 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 49 | AP | 2013-08-14 | STANDARD |
| LABELING; Labeling | SUPPL | 55 | AP | 2013-05-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 56 | AP | 2013-03-27 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 57 | AP | 2013-10-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 58 | AP | 2013-07-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 59 | AP | 2013-06-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 61 | AP | 2014-09-05 | STANDARD |
| LABELING; Labeling | SUPPL | 62 | AP | 2015-02-25 | 901 REQUIRED |
| EFFICACY; Efficacy | SUPPL | 63 | AP | 2015-07-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 64 | AP | 2015-06-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 65 | AP | 2016-04-13 | STANDARD |
| LABELING; Labeling | SUPPL | 71 | AP | 2018-11-29 | STANDARD |
| LABELING; Labeling | SUPPL | 72 | AP | 2019-05-09 | STANDARD |
| LABELING; Labeling | SUPPL | 73 | AP | 2019-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 74 | AP | 2019-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 76 | AP | 2022-06-07 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 26 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 34 | Null | 6 |
| SUPPL | 49 | Null | 0 |
| SUPPL | 55 | Null | 7 |
| SUPPL | 56 | Null | 0 |
| SUPPL | 57 | Null | 15 |
| SUPPL | 58 | Null | 0 |
| SUPPL | 59 | Null | 0 |
| SUPPL | 61 | Null | 0 |
| SUPPL | 62 | Null | 15 |
| SUPPL | 63 | Null | 15 |
| SUPPL | 64 | Null | 0 |
| SUPPL | 65 | Null | 0 |
| SUPPL | 71 | Null | 7 |
| SUPPL | 72 | Null | 7 |
| SUPPL | 73 | Null | 15 |
| SUPPL | 74 | Null | 6 |
| SUPPL | 76 | Null | 6 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 21081
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"LANTUS","activeIngredients":"INSULIN GLARGINE RECOMBINANT","strength":"100 UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"},{"drugName":"LANTUS SOLOSTAR","activeIngredients":"INSULIN GLARGINE RECOMBINANT","strength":"300 UNITS\/3ML (100 UNITS\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
[labels] => [{"actionDate":"11\/15\/2019","submission":"SUPPL-74","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021081s073s074lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2019","submission":"SUPPL-74","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021081s073s074lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21081lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"LANTUS","submission":"INSULIN GLARGINE RECOMBINANT","actionType":"100 UNITS\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LANTUS SOLOSTAR","submission":"INSULIN GLARGINE RECOMBINANT","actionType":"300 UNITS\/3ML (100 UNITS\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2019-11-15
)
)