Labetalol Cartridge
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Hospira, Inc. (2015-10-19)
- Oldest Current Product
- 1999-11-29
- License(s)
- ANDA
- RxNORM
- CARTRIDGE\LABETALOL
- FDAOB
- INJECTION\INJECTION\LABETALOL HYDROCHLORIDE\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, SOLUTION\LABETALOL HYDROCHLORIDE
- SPL Moiety
- INTRAVENOUS\INJECTION, SOLUTION\LABETALOL
product(s) by strength(s)
4 ml labetalol hydrochloride 5 mg/ml cartridge
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 004092339 | ANDA | Hospira, Inc. | 1999-11-29 | LABETALOL HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | ANDA075239 | d3579d45-a964-40fe-e3a2-a3a997c8b7b9 |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 551544747 | ANDA | Cardinal Health | 1999-11-29 | LABETALOL HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | 004092339 | ANDA075239 | 1b96ddc9-d0c3-488a-a113-66491fd3d899 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug | in other drug docs |
|---|---|---|---|---|---|---|---|
| 1 | ANDA075239 | LABETALOL HYDROCHLORIDE | HOSPIRA INC | 1999-11-29 | ANDA075239_001 | Labetalol Injectable Solution | |
| 2 | ANDA075240 | LABETALOL HYDROCHLORIDE | HOSPIRA INC | 1999-11-29 | ANDA075240_001 | Labetalol Injectable Solution | |
| 3 | ANDA075242 | LABETALOL HYDROCHLORIDE | True | HOSPIRA INC | 1999-09-30 | ANDA075242_001 | Labetalol Injectable Solution |
| 4 | ANDA075303 | LABETALOL HYDROCHLORIDE | EUROHEALTH INTERNATIONAL SARL | 1999-05-28 | ANDA075303_001 | Labetalol Injectable Solution | |
| 5 | ANDA075355 | LABETALOL HYDROCHLORIDE | True | APOTHECON INC DIV BRISTOL MYERS SQUIBB | 1999-11-29 | ANDA075355_001 | Labetalol Injectable Solution |
| 6 | ANDA075431 | LABETALOL HYDROCHLORIDE | AKORN INC | 1999-11-29 | ANDA075431_001 | Labetalol Injectable Solution | |
| 7 | ANDA075524 | LABETALOL HYDROCHLORIDE | AKORN INC | 1999-11-29 | ANDA075524_001 | Labetalol Injectable Solution | |
| 8 | ANDA076051 | LABETALOL HYDROCHLORIDE | True | CLARIS PHARMASERVICES | 2002-07-05 | ANDA076051_001 | Labetalol Injectable Solution |
| 9 | ANDA079134 | LABETALOL HYDROCLORIDE | SAGENT STRIDES LLC | 2010-02-03 | ANDA079134_001 | Labetalol Injectable Solution | |
| 10 | ANDA090699 | LABETALOL HYDROCHLORIDE | GLAND PHARMA LTD | 2012-04-03 | ANDA090699_001 | Labetalol Injectable Solution | |
| 11 | NDA018686 | NORMODYNE | True | SCHERING CORP SUB SCHERING PLOUGH CORP | 1984-08-01 | NDA018686_001 | Labetalol Injectable Solution |
| 12 | NDA019425 | TRANDATE | True | PROMETHEUS LABORATORIES INC | 1985-12-31 | NDA019425_001 | Labetalol Injectable Solution |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA075239_001 | RX | LABETALOL HYDROCHLORIDE (5MG/ML) | INJECTION | True | AP | 1999-11-29 | LABETALOL HYDROCHLORIDE |
| 2 | ANDA075240_001 | RX | LABETALOL HYDROCHLORIDE (5MG/ML) | INJECTION | True | AP | 1999-11-29 | LABETALOL HYDROCHLORIDE |
| 3 | ANDA075242_001 | discontinued | LABETALOL HYDROCHLORIDE (5MG/ML) | INJECTION | False | 1999-09-30 | LABETALOL HYDROCHLORIDE | |
| 4 | ANDA075303_001 | RX | LABETALOL HYDROCHLORIDE (5MG/ML) | INJECTION | False | AP | 1999-05-28 | LABETALOL HYDROCHLORIDE |
| 5 | ANDA075355_001 | discontinued | LABETALOL HYDROCHLORIDE (5MG/ML) | INJECTION | False | 1999-11-29 | LABETALOL HYDROCHLORIDE | |
| 6 | ANDA075431_001 | RX | LABETALOL HYDROCHLORIDE (5MG/ML) | INJECTION | False | AP | 1999-11-29 | LABETALOL HYDROCHLORIDE |
| 7 | ANDA075524_001 | RX | LABETALOL HYDROCHLORIDE (5MG/ML) | INJECTION | False | AP | 1999-11-29 | LABETALOL HYDROCHLORIDE |
| 8 | ANDA076051_001 | discontinued | LABETALOL HYDROCHLORIDE (5MG/ML) | INJECTION | False | 2002-07-05 | LABETALOL HYDROCHLORIDE | |
| 9 | ANDA079134_001 | RX | LABETALOL HYDROCHLORIDE (5MG/ML) | INJECTION | False | AP | 2010-02-03 | LABETALOL HYDROCLORIDE |
| 10 | ANDA090699_001 | RX | LABETALOL HYDROCHLORIDE (5MG/ML) | INJECTION | False | AP | 2012-04-03 | LABETALOL HYDROCHLORIDE |
| 11 | NDA018686_001 | discontinued | LABETALOL HYDROCHLORIDE (5MG/ML) | INJECTION | False | 1984-08-01 | NORMODYNE | |
| 12 | NDA019425_001 | discontinued | LABETALOL HYDROCHLORIDE (5MG/ML) | INJECTION | False | 1985-12-31 | TRANDATE |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 1b96ddc9-d0c3-488a-a113-66491fd3d899 (view SPL) | Labetalol Hydrochloride | prescription | Human Prescription | Cardinal Health | REPACK | 2014-07-08 | 1 | 551544747 |
| 2 | d3579d45-a964-40fe-e3a2-a3a997c8b7b9 (view SPL) | Labetalol Hydrochloride | prescription | Human Prescription | Hospira, Inc. | 2015-10-19 | 13 | 004092339 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII