liraglutide Pen Injector
- Brand(s)
- Saxenda, Victoza
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Novo Nordisk (2015-11-10)
- Oldest Current Product
- 2010-01-25
- License(s)
- NDA
- RxNORM
- PEN INJECTOR\LIRAGLUTIDE
- FDAOB
- SUBCUTANEOUS\SOLUTION\LIRAGLUTIDE RECOMBINANT
- SPL Active
- SUBCUTANEOUS\INJECTION, SOLUTION\LIRAGLUTIDE
- SPL Moiety
- SUBCUTANEOUS\INJECTION, SOLUTION\LIRAGLUTIDE
product(s) by strength(s)
3 ml liraglutide 6 mg/ml pen injector
original product(s)(s)
# | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
---|---|---|---|---|---|---|---|---|---|---|
1 | 001694060 | Victoza | NDA | Novo Nordisk | 2010-01-25 | LIRAGLUTIDE | SUBCUTANEOUS | INJECTION, SOLUTION | NDA022341 | 5a9ef4ea-c76a-4d34-a604-27c5b505f5a4 |
application(s)
# | id | title | applicant | approved | patent | exclusivity | approved drug |
---|---|---|---|---|---|---|---|
1 | NDA022341 | VICTOZA | NOVO NORDISK INC | 2010-01-25 | p8846618, SUBSTANCE p6004297, SUBSTANCE p6268343, A METHOD FOR IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS, SUBSTANCE pRE43834, SUBSTANCE p6458924, A METHOD FOR IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS, SUBSTANCE p8114833, SUBSTANCE pRE41956, SUBSTANCE p7235627, SUBSTANCE | REVISIONS TO THE PI BASED ON RESULTS FROM STUDY NN2211-1842 [2015-04-06] NEW CHEMICAL ENTITY [2015-01-25] | NDA022341_001 |
2 | NDA206321 | SAXENDA | NOVO NORDISK INC | 2014-12-23 | p9132239, SUBSTANCE p7686786, SUBSTANCE p8846618, SUBSTANCE p8684969, SUBSTANCE p8672898, SUBSTANCE p6899699, SUBSTANCE p8920383, SUBSTANCE p8114833, SUBSTANCE p6268343, METHOD FOR CHRONIC WEIGHT MANAGEMENT BY TREATING OBESITY, SUBSTANCE p6458924, METHOD FOR CHRONIC WEIGHT MANAGEMENT BY TREATING OBESITY, SUBSTANCE p9108002, SUBSTANCE p7235627, SUBSTANCE | NEW CHEMICAL ENTITY [2015-01-25] NEW PRODUCT [2017-01-25] | NDA206321_001 |
application drug(s)
# | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
---|---|---|---|---|---|---|---|---|
1 | NDA022341_001 | RX | LIRAGLUTIDE RECOMBINANT (18MG/3ML) | SUBCUTANEOUS | SOLUTION | True | 2010-01-25 | VICTOZA |
2 | NDA206321_001 | RX | LIRAGLUTIDE RECOMBINANT (18MG/3ML) | SUBCUTANEOUS | SOLUTION | True | 2014-12-23 | SAXENDA |
patent(s)
spl(s)
# | id | title | category | type | labeler | labeler act | last update | version | product(s) |
---|---|---|---|---|---|---|---|---|---|
1 | 3946d389-0926-4f77-a708-0acb8153b143 (view SPL) | These highlights do not include all the information needed to use SAXENDA safely and effectively. See full prescribing information for SAXENDA. SAXENDA (liraglutide [rDNA origin] injection), solution for subcutaneous useInitial U.S. Approval: 2010 | prescription | Human Prescription | Novo Nordisk | API MANUFACTURE, MANUFACTURE | 2015-11-10 | 4 | 001692800 |
2 | 5a9ef4ea-c76a-4d34-a604-27c5b505f5a4 (view SPL) | These highlights do not include all the information needed to use Victoza safely and effectively. See full prescribing information for Victoza.Victoza (liraglutide [rDNA origin] injection), solution for subcutaneous useInitial U.S. Approval: 2010 | prescription | Human Prescription | Novo Nordisk | API MANUFACTURE, MANUFACTURE | 2015-11-10 | 15 | 001694060 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII