Insulin Glargine Pen Injector
- Brand(s)
- Lantus, Toujeo
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Sanofi-Aventis U.S. Llc (2015-10-15)
- Oldest Current Product
- 2007-04-04
- License(s)
- NDA
- RxNORM
- PEN INJECTOR\INSULIN GLARGINE
- FDAOB
- INJECTION\INJECTION\INSULIN GLARGINE RECOMBINANT\rdfq
SUBCUTANEOUS\SOLUTION\INSULIN GLARGINE RECOMBINANT - SPL Active
- SUBCUTANEOUS\INJECTION, SOLUTION\INSULIN GLARGINE
- SPL Moiety
- SUBCUTANEOUS\INJECTION, SOLUTION\INSULIN GLARGINE
product(s) by strength(s)
3 ml insulin glargine 100 unt/ml pen injector
original product(s)(s)
# | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
---|---|---|---|---|---|---|---|---|---|---|
1 | 000882219 | Lantus | NDA | Sanofi-Aventis U.S. Llc | 2009-09-23 | INSULIN GLARGINE | SUBCUTANEOUS | INJECTION, SOLUTION | NDA021081 | d5e07a0c-7e14-4756-9152-9fea485d654a |
relabeler product(s)(s)
# | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
---|---|---|---|---|---|---|---|---|---|---|---|
1 | 548685765 | Lantus | NDA | Physicians Total Care, Inc. | 2007-04-04 | INSULIN GLARGINE | SUBCUTANEOUS | INJECTION, SOLUTION | 000882220 | NDA021081 | b861fdd9-e134-436e-8c0c-a60dd0006dd3 |
2 | 548686231 | Lantus | NDA | Physicians Total Care, Inc. | 2011-02-07 | INSULIN GLARGINE | SUBCUTANEOUS | INJECTION, SOLUTION | 000882219 | NDA021081 | b861fdd9-e134-436e-8c0c-a60dd0006dd3 |
1.5 ml insulin glargine 300 unt/ml pen injector
original product(s)(s)
# | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
---|---|---|---|---|---|---|---|---|---|---|
1 | 000245869 | Toujeo | NDA | Sanofi-Aventis U.S. Llc | 2015-02-25 | INSULIN GLARGINE | SUBCUTANEOUS | INJECTION, SOLUTION | NDA206538 | c9561d96-124d-48ca-982f-0aa1575bff36 |
application(s)
# | id | title | applicant | approved | patent | exclusivity | approved drug | in other drug docs |
---|---|---|---|---|---|---|---|---|
1 | NDA021081 | LANTUS | SANOFI AVENTIS US LLC | 2000-04-20 | p9011391, SUBSTANCE p8603044, SUBSTANCE p5656722, TREATMENT OF DIABETES MELLITUS, SUBSTANCE p8992486, SUBSTANCE p7918833, SUBSTANCE p8512297, SUBSTANCE p7713930, SUBSTANCE p8679069, SUBSTANCE p8556864, SUBSTANCE p7476652, SUBSTANCE | NDA021081_001, NDA021081_002 | Insulin Glargine Injectable Solution | |
2 | NDA206538 | TOUJEO SOLOSTAR | SANOFI US SERVICES INC | 2015-02-25 | p8603044, SUBSTANCE p8992486, SUBSTANCE p7918833, SUBSTANCE p8556864, SUBSTANCE p9011391, SUBSTANCE p8679069, SUBSTANCE p8512297, SUBSTANCE | NEW PRODUCT [2018-02-25] | NDA206538_001 |
application drug(s)
# | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
---|---|---|---|---|---|---|---|---|
1 | NDA021081_001 | RX | INSULIN GLARGINE RECOMBINANT (100 UNITS/ML) | INJECTION | True | 2000-04-20 | LANTUS | |
2 | NDA021081_002 | RX | INSULIN GLARGINE RECOMBINANT (300 UNITS/3ML) | INJECTION | True | 2007-04-27 | LANTUS | |
3 | NDA206538_001 | RX | INSULIN GLARGINE RECOMBINANT (300 UNITS/ML) | SUBCUTANEOUS | SOLUTION | True | 2015-02-25 | TOUJEO SOLOSTAR |
patent(s)
spl(s)
# | id | title | category | type | labeler | labeler act | last update | version | product(s) | in other drug docs |
---|---|---|---|---|---|---|---|---|---|---|
1 | b861fdd9-e134-436e-8c0c-a60dd0006dd3 (view SPL) | These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000 | prescription | Human Prescription | Physicians Total Care, Inc. | relabel | 2010-01-05 | 2 | 548685765, 548686231, 548684626 | Insulin Glargine Injectable Solution |
2 | c9561d96-124d-48ca-982f-0aa1575bff36 (view SPL) | These highlights do not include all the information needed to use TOUJEO safely and effectively. See full prescribing information for TOUJEO. TOUJEO (insulin glargine injection) U-300, for subcutaneous useInitial U.S. Approval: 2015 | prescription | Human Prescription | Sanofi-Aventis U.S. Llc | ANALYSIS, LABEL, MANUFACTURE, PACK | 2015-10-15 | 7 | 000245869 | |
3 | d5e07a0c-7e14-4756-9152-9fea485d654a (view SPL) | These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine injection) solution for subcutaneous injectionInitial U.S. Approval: 2000 | prescription | Human Prescription | Sanofi-Aventis U.S. Llc | ANALYSIS, LABEL, MANUFACTURE, PACK | 2015-08-05 | 22 | 000882219, 000882220 | Insulin Glargine Injectable Solution |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII