Documents
Application Sponsors
| NDA 022341 | NOVO NORDISK INC | |
Marketing Status
Application Products
| 001 | SOLUTION;SUBCUTANEOUS | 18MG/3ML (6MG/ML) | 1 | VICTOZA | LIRAGLUTIDE RECOMBINANT |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2010-01-25 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2011-05-18 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2012-04-06 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 9 | AP | 2012-04-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2012-12-03 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2012-04-06 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2012-12-13 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2013-04-16 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2013-06-13 | STANDARD |
| REMS; REMS | SUPPL | 21 | AP | 2014-07-31 | N/A |
| LABELING; Labeling | SUPPL | 22 | AP | 2015-02-25 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 23 | AP | 2015-03-09 | 901 REQUIRED |
| REMS; REMS | SUPPL | 24 | AP | 2015-07-01 | N/A |
| EFFICACY; Efficacy | SUPPL | 25 | AP | 2016-04-22 | STANDARD |
| REMS; REMS | SUPPL | 26 | AP | 2016-09-20 | N/A |
| EFFICACY; Efficacy | SUPPL | 27 | AP | 2017-08-25 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2017-04-25 | STANDARD |
| REMS; REMS | SUPPL | 29 | AP | 2017-07-26 | N/A |
| EFFICACY; Efficacy | SUPPL | 31 | AP | 2019-06-17 | PRIORITY |
| LABELING; Labeling | SUPPL | 35 | AP | 2020-08-05 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2020-11-20 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2022-06-10 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2022-06-10 | 901 REQUIRED |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 18 | Null | 15 |
| SUPPL | 20 | Null | 15 |
| SUPPL | 21 | Null | 31 |
| SUPPL | 22 | Null | 6 |
| SUPPL | 23 | Null | 6 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 25 | Null | 7 |
| SUPPL | 26 | Null | 15 |
| SUPPL | 27 | Null | 15 |
| SUPPL | 28 | Null | 6 |
| SUPPL | 29 | Null | 7 |
| SUPPL | 31 | Null | 6 |
| SUPPL | 35 | Null | 7 |
| SUPPL | 36 | Null | 15 |
| SUPPL | 37 | Null | 6 |
| SUPPL | 38 | Null | 6 |
CDER Filings
NOVO NORDISK INC
cder:Array
(
[0] => Array
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[companyName] => NOVO NORDISK INC
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[originalApprovals] => [{"actionDate":"VICTOZA","submission":"LIRAGLUTIDE RECOMBINANT","actionType":"18MG\/3ML (6MG\/ML)","submissionClassification":"SOLUTION;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-08-05
)
)