Insulin Lispro Pen Injector
- Brand(s)
- Humalog
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Eli Lilly And Company (2015-08-04)
- Oldest Current Product
- 2008-01-16
- License(s)
- NDA
- RxNORM
- PEN INJECTOR\INSULIN LISPRO
- FDAOB
- INJECTION\INJECTION\INSULIN LISPRO RECOMBINANT\rdfq
SUBCUTANEOUS\SOLUTION\INSULIN LISPRO RECOMBINANT - SPL Active
- SUBCUTANEOUS\INJECTION, SOLUTION\INSULIN LISPRO
- SPL Moiety
- SUBCUTANEOUS\INJECTION, SOLUTION\INSULIN LISPRO
product(s) by strength(s)
3 ml insulin lispro 100 unt/ml pen injector
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000028799 | Humalog | NDA | Eli Lilly And Company | 2008-01-16 | INSULIN LISPRO | SUBCUTANEOUS | INJECTION, SOLUTION | NDA020563 | c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 548685899 | Humalog | NDA | Physicians Total Care, Inc. | 2008-05-12 | INSULIN LISPRO | SUBCUTANEOUS | INJECTION, SOLUTION | 000028725 | NDA020563 | ce8354f4-bf07-4923-8755-47f3163662e4 |
3 ml insulin lispro 200 unt/ml pen injector
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000027712 | Humalog | NDA | Eli Lilly And Company | 2015-05-26 | INSULIN LISPRO | SUBCUTANEOUS | INJECTION, SOLUTION | NDA205747 | c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug | in other drug docs |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA020563 | HUMALOG | ELI LILLY AND CO | 1996-06-14 | p7291132, SUBSTANCE | NEW ROUTE [2015-10-12] | NDA020563_001, NDA020563_002, NDA020563_003 | Insulin Lispro Injectable Solution Insulin Lispro Cartridge |
| 2 | NDA205747 | HUMALOG KWIKPEN | ELI LILLY AND CO | 2015-05-26 | p7291132, SUBSTANCE p6034054, TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS./ TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS AND SYMPTOMS THEREOF., SUBSTANCE p6551992, TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS./ TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS AND SYMPTOMS THEREOF., SUBSTANCE | NDA205747_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA020563_001 | RX | INSULIN LISPRO RECOMBINANT (100 UNITS/ML) | INJECTION | True | 1996-06-14 | HUMALOG | |
| 2 | NDA020563_002 | discontinued | INSULIN LISPRO RECOMBINANT (100 UNITS/ML) | INJECTION | False | 1998-08-06 | HUMALOG | |
| 3 | NDA020563_003 | RX | INSULIN LISPRO RECOMBINANT (100 UNITS/ML) | INJECTION | True | 2007-09-06 | HUMALOG | |
| 4 | NDA205747_001 | RX | INSULIN LISPRO RECOMBINANT (200 UNITS/ML) | SUBCUTANEOUS | SOLUTION | True | 2015-05-26 | HUMALOG KWIKPEN |
patent(s)
| # | id | expiration date | application(s) | in other drug docs |
|---|---|---|---|---|
| 1 | p6034054 (view patent) | 2018-06-11 | NDA205747 | |
| 2 | p6551992 (view patent) | 2018-06-11 | NDA205747 | |
| 3 | p7291132 (view patent) | 2024-08-09 | NDA020563, NDA205747, NDA018781, NDA019717, NDA021017, NDA021018 | insulin, isophane / Regular Insulin, Human Injectable Suspension insulin, isophane Injectable Suspension Insulin Lispro / Insulin, Protamine Lispro, Human Injectable Suspension Insulin Lispro Injectable Solution Insulin Lispro Cartridge Insulin Lispro / Insulin, Protamine Lispro, Human Pen Injector |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) | in other drug docs |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f (view SPL) | These highlights do not include all the information needed to use HUMALOG safely and effectively. See full prescribing information for HUMALOG.HUMALOG (insulin lispro injection), for subcutaneous or intravenous useInitial U.S. Approval: 1996 | prescription | Human Prescription | Eli Lilly And Company | 2015-08-04 | 48 | 000027712, 000028799, 000027510, 000027516 | Insulin Lispro Injectable Solution Insulin Lispro Cartridge | |
| 2 | ce8354f4-bf07-4923-8755-47f3163662e4 (view SPL) | These highlights do not include all the information needed to use HUMALOG safely and effectively. See full prescribing information for HUMALOG.Humalog (insulin lispro injection, USP [rDNA origin]) for injectionInitial U.S. Approval: 1996 | prescription | Human Prescription | Physicians Total Care, Inc. | relabel | 2012-05-22 | 3 | 548685899, 548685108, 548685836 | Insulin Lispro Injectable Solution Insulin Lispro Cartridge |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII