Documents
Application Sponsors
| BLA 021536 | NOVO NORDISK INC | |
Marketing Status
| Prescription | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
| Prescription | 005 |
Application Products
| 001 | INJECTABLE;SUBCUTANEOUS | 1000 UNITS/10ML (100 UNITS/ML) | 0 | LEVEMIR | INSULIN DETEMIR RECOMBINANT |
| 002 | INJECTABLE;SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | 0 | LEVEMIR FLEXPEN | INSULIN DETEMIR RECOMBINANT |
| 003 | INJECTABLE;SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | 0 | LEVEMIR INNOLET | INSULIN DETEMIR RECOMBINANT |
| 004 | INJECTABLE;SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | 0 | LEVEMIR PENFILL | INSULIN DETEMIR RECOMBINANT |
| 005 | INJECTABLE;SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | 0 | LEVEMIR FLEXTOUCH | INSULIN DETEMIR RECOMBINANT |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2005-06-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2007-05-16 | N/A |
| LABELING; Labeling | SUPPL | 20 | AP | 2008-09-03 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2008-09-03 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2008-11-28 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2009-05-07 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2012-11-05 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2012-01-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2010-01-22 | N/A |
| LABELING; Labeling | SUPPL | 31 | AP | 2015-02-25 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2013-10-31 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2013-03-09 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 37 | AP | 2012-03-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 39 | AP | 2012-04-27 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 41 | AP | 2012-05-18 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 2013-04-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 2013-02-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 2014-03-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 47 | AP | 2014-06-10 | STANDARD |
| LABELING; Labeling | SUPPL | 48 | AP | 2014-02-25 | STANDARD |
| LABELING; Labeling | SUPPL | 50 | AP | 2015-01-23 | STANDARD |
| LABELING; Labeling | SUPPL | 51 | AP | 2015-02-25 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 54 | AP | 2019-01-17 | STANDARD |
| LABELING; Labeling | SUPPL | 56 | AP | 2019-12-27 | STANDARD |
| LABELING; Labeling | SUPPL | 57 | AP | 2019-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 58 | AP | 2019-11-15 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 60 | AP | 2022-07-01 | STANDARD |
| LABELING; Labeling | SUPPL | 62 | AP | 2022-12-08 | STANDARD |
Submissions Property Types
| SUPPL | 28 | Null | 7 |
| SUPPL | 29 | Null | 15 |
| SUPPL | 31 | Null | 7 |
| SUPPL | 33 | Null | 7 |
| SUPPL | 35 | Null | 7 |
| SUPPL | 37 | Null | 7 |
| SUPPL | 39 | Null | 6 |
| SUPPL | 41 | Null | 15 |
| SUPPL | 44 | Null | 7 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 47 | Null | 0 |
| SUPPL | 48 | Null | 15 |
| SUPPL | 50 | Null | 15 |
| SUPPL | 51 | Null | 31 |
| SUPPL | 54 | Null | 7 |
| SUPPL | 56 | Null | 6 |
| SUPPL | 57 | Null | 7 |
| SUPPL | 58 | Null | 15 |
| SUPPL | 60 | Null | 7 |
| SUPPL | 62 | Null | 6 |
CDER Filings
NOVO NORDISK INC
cder:Array
(
[0] => Array
(
[ApplNo] => 21536
[companyName] => NOVO NORDISK INC
[docInserts] => ["",""]
[products] => [{"drugName":"LEVEMIR","activeIngredients":"INSULIN DETEMIR RECOMBINANT","strength":"1000 UNITS\/10ML (100 UNITS\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"LEVEMIR FLEXPEN","activeIngredients":"INSULIN DETEMIR RECOMBINANT","strength":"300 UNITS\/3ML (100 UNITS\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LEVEMIR FLEXTOUCH","activeIngredients":"INSULIN DETEMIR RECOMBINANT","strength":"300 UNITS\/3ML (100 UNITS\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"LEVEMIR INNOLET","activeIngredients":"INSULIN DETEMIR RECOMBINANT","strength":"300 UNITS\/3ML (100 UNITS\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LEVEMIR PENFILL","activeIngredients":"INSULIN DETEMIR RECOMBINANT","strength":"300 UNITS\/3ML (100 UNITS\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"11\/15\/2019","submission":"SUPPL-58","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021536s057s058lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2019","submission":"SUPPL-58","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021536s057s058lbl.pdf\"}]","notes":""},{"actionDate":"06\/16\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021536lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"LEVEMIR","submission":"INSULIN DETEMIR RECOMBINANT","actionType":"1000 UNITS\/10ML (100 UNITS\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVEMIR FLEXPEN","submission":"INSULIN DETEMIR RECOMBINANT","actionType":"300 UNITS\/3ML (100 UNITS\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LEVEMIR FLEXTOUCH","submission":"INSULIN DETEMIR RECOMBINANT","actionType":"300 UNITS\/3ML (100 UNITS\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVEMIR INNOLET","submission":"INSULIN DETEMIR RECOMBINANT","actionType":"300 UNITS\/3ML (100 UNITS\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LEVEMIR PENFILL","submission":"INSULIN DETEMIR RECOMBINANT","actionType":"300 UNITS\/3ML (100 UNITS\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2019-11-15
)
)