Application 022341
- Type
- NDA
- Sponsor
- NOVO NORDISK INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VICTOZA | LIRAGLUTIDE RECOMBINANT | SOLUTION;SUBCUTANEOUS | 18MG/3ML (6MG/ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0169-4060 | Victoza | liraglutide | Novo Nordisk | NDA | Current |
| 0169-4060 | Victoza | liraglutide | Novo Nordisk | NDA | Current |
| 0169-4060 | Victoza | liraglutide | Novo Nordisk | NDA | Current |
| 0169-4060 | Victoza | liraglutide | Novo Nordisk | NDA | Current |
| 0169-4060 | Victoza | liraglutide | Novo Nordisk | NDA | Current |
| 0169-4060 | Victoza | liraglutide | Novo Nordisk | NDA | Current |
| 0169-4060 | Victoza | liraglutide | Novo Nordisk | NDA | Current |
| 50090-2853 | Victoza | liraglutide | A-S Medication Solutions | NDA | Current |
| 50090-4503 | Victoza | liraglutide | A-S Medication Solutions | NDA | Current |
| 50090-4503 | Victoza | liraglutide | A-S Medication Solutions | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83787 | SUPPL | 2025-10-15 |
| 83786 | SUPPL | 2025-10-15 |
| 83771 | SUPPL | 2025-10-15 |
| 82371 | SUPPL | 2025-05-30 |
| 81252 | SUPPL | 2025-02-21 |
| 81237 | SUPPL | 2025-02-13 |
| 80065 | SUPPL | 2024-11-01 |
| 80064 | SUPPL | 2024-11-01 |
| 74710 | SUPPL | 2023-07-07 |
| 74703 | SUPPL | 2023-07-06 |
| 71328 | SUPPL | 2022-06-15 |
| 71327 | SUPPL | 2022-06-15 |
| 71280 | SUPPL | 2022-06-13 |
| 71279 | SUPPL | 2022-06-13 |
| 65317 | SUPPL | 2020-11-25 |
| 65316 | SUPPL | 2020-11-25 |
| 65307 | SUPPL | 2020-11-25 |
| 64220 | SUPPL | 2020-08-06 |
| 64212 | SUPPL | 2020-08-06 |
| 64211 | SUPPL | 2020-08-06 |
| 64010 | SUPPL | 2020-07-22 |
| 59152 | SUPPL | 2019-06-21 |
| 59151 | SUPPL | 2019-06-21 |
| 59110 | SUPPL | 2019-06-18 |
| 49554 | SUPPL | 2017-08-28 |
| 49547 | SUPPL | 2017-08-28 |
| 49108 | SUPPL | 2017-07-28 |
| 48151 | SUPPL | 2017-04-27 |
| 48119 | SUPPL | 2017-04-26 |
| 45358 | SUPPL | 2016-09-22 |
| 17275 | SUPPL | 2016-04-27 |
| 7270 | SUPPL | 2016-04-26 |
| 29625 | SUPPL | 2015-07-08 |
| 17274 | SUPPL | 2015-03-26 |
| 7269 | SUPPL | 2015-03-11 |
| 38603 | SUPPL | 2015-03-03 |
| 7268 | SUPPL | 2015-02-27 |
| 29624 | SUPPL | 2014-08-01 |
| 38602 | SUPPL | 2013-06-18 |
| 7267 | SUPPL | 2013-06-14 |
| 29623 | SUPPL | 2013-04-18 |
| 17273 | SUPPL | 2013-04-17 |
| 29622 | SUPPL | 2012-12-19 |
| 17272 | SUPPL | 2012-12-18 |
| 38601 | SUPPL | 2012-04-09 |
| 38600 | SUPPL | 2012-04-09 |
| 29621 | SUPPL | 2012-04-09 |
| 17271 | SUPPL | 2012-04-09 |
| 7266 | SUPPL | 2012-04-09 |
| 7265 | SUPPL | 2012-04-09 |
| 29620 | SUPPL | 2011-05-24 |
| 38599 | SUPPL | 2011-05-23 |
| 38598 | SUPPL | 2010-12-26 |
| 42495 | ORIG | 2010-04-06 |
| 29619 | ORIG | 2010-01-26 |
| 17270 | ORIG | 2010-01-26 |
| 64949 | ORIG | 1900-01-01 |
| 63984 | ORIG | 1900-01-01 |
| 63983 | ORIG | 1900-01-01 |
| 63982 | ORIG | 1900-01-01 |
| 63120 | SUPPL | 1900-01-01 |
| 63119 | SUPPL | 1900-01-01 |