esmolol Injectable Solution
- Brand(s)
- Brevibloc
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Baxter Healthcare Corporation (2014-04-01)
- Oldest Current Product
- 1986-12-31
- License(s)
- NDA, ANDA
- RxNORM
- INJECTABLE SOLUTION\ESMOLOL
- FDAOB
- INJECTION\INJECTION\ESMOLOL HYDROCHLORIDE\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, SOLUTION\ESMOLOL HYDROCHLORIDE
INTRAVENOUS\INJECTION\ESMOLOL HYDROCHLORIDE - SPL Moiety
- INTRAVENOUS\INJECTION, SOLUTION\ESMOLOL
INTRAVENOUS\INJECTION\ESMOLOL
product(s) by strength(s)
esmolol hydrochloride 10 mg/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 006412965 | NDA | West-Ward Pharmaceuticals Corp. | 1986-12-31 | ESMOLOL HYDROCHLORIDE | INTRAVENOUS | INJECTION | NDA019386 | a70baf53-e38a-4b23-8905-ee284170236d | |
| 2 | 100190055 | Brevibloc | NDA | Baxter Healthcare Corporation | 1986-12-31 | ESMOLOL HYDROCHLORIDE | INTRAVENOUS | INJECTION | NDA019386 | 595cc3d5-1306-4828-aefa-5595219ffd62 |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 551500194 | ANDA | Auromedics Pharma Llc | 2015-07-23 | ESMOLOL HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | ANDA205520 | ac22475d-2d78-469f-9435-b403ac4ee380 |
| 2 | 633230652 | ANDA | App Pharmaceuticals, Llc | 2004-11-30 | ESMOLOL HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | ANDA076573 | fdc9cea8-0eb4-4930-9e1c-d44bfa9346d2 |
| 3 | 674570182 | ANDA | Mylan Institutional Llc | 2013-02-21 | ESMOLOL HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | ANDA076474 | 94f069f9-dd52-4a69-a103-ebdb4294f088 |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 525840017 | NDA | General Injecatables & Vaccines, Inc | 2010-04-01 | ESMOLOL HYDROCHLORIDE | INTRAVENOUS | INJECTION | 006412965 | NDA019386 | 35460df2-18d3-4132-85e6-5289bad4c670 |
| 2 | 525840049 | ANDA | General Injecatables & Vaccines, Inc | 2015-09-10 | ESMOLOL HYDROCHLORIDE | INTRAVENOUS | INJECTION | 674570182 | ANDA076474 | a2e031a3-10ab-40e5-a421-eb54d00c0ac5 |
| 3 | 525840062 | ANDA | General Injecatables & Vaccines, Inc | 2010-08-01 | ESMOLOL HYDROCHLORIDE | INTRAVENOUS | INJECTION | 553900062 | ANDA076323 | f1a60c72-a4e3-437d-b472-8d5bffc91273 |
| 4 | 525840115 | NDA | General Injecatables & Vaccines, Inc | 2010-07-01 | ESMOLOL HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | 100190115 | NDA019386 | c8d2e135-ec31-4eee-bce2-c85e7858c5e1 |
| 5 | 525840652 | ANDA | General Injecatables & Vaccines, Inc | 2012-06-13 | ESMOLOL HYDROCHLORIDE | INTRAVENOUS | INJECTION | 633230652 | ANDA076573 | b0df082a-838f-4556-8399-dd8229c5974a |
| 6 | 551542888 | NDA | Cardinal Health | 1986-12-31 | ESMOLOL HYDROCHLORIDE | INTRAVENOUS | INJECTION | 100190120 | NDA019386 | 6dcbdd78-c69d-4d70-81ce-8cb7f7580b48 |
esmolol hydrochloride 20 mg/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 100190075 | Brevibloc | NDA | Baxter Healthcare Corporation | 1986-12-31 | ESMOLOL HYDROCHLORIDE | INTRAVENOUS | INJECTION | NDA019386 | 595cc3d5-1306-4828-aefa-5595219ffd62 |
application(s)
| # | id | title | applicant | approved | patent | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA076323 | ESMOLOL HYDROCHLORIDE | EUROHEALTH INTERNATIONAL SARL | 2004-08-10 | ANDA076323_001 | |
| 2 | ANDA076474 | ESMOLOL HYDROCHLORIDE | MYLAN INSTITUTIONAL LLC | 2005-05-02 | ANDA076474_001 | |
| 3 | ANDA076573 | ESMOLOL HYDROCHLORIDE | FRESENIUS KABI USA LLC | 2005-05-02 | ANDA076573_001 | |
| 4 | ANDA201126 | ESMOLOL HYDROCHLORIDE | LUITPOLD PHARMACEUTICALS INC | 2015-02-20 | ANDA201126_001 | |
| 5 | ANDA205520 | ESMOLOL HYDROCHLORIDE | AUROBINDO PHARMA LTD | 2015-07-23 | ANDA205520_001 | |
| 6 | NDA019386 | BREVIBLOC | BAXTER HEALTHCARE CORP | 1988-08-15 | p6310094 p6528540 | NDA019386_003, NDA019386_004, NDA019386_005, NDA019386_006, NDA019386_007 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA076323_001 | RX | ESMOLOL HYDROCHLORIDE (10MG/ML) | INJECTION | False | AP | 2004-08-10 | ESMOLOL HYDROCHLORIDE |
| 2 | ANDA076474_001 | RX | ESMOLOL HYDROCHLORIDE (10MG/ML) | INJECTION | False | AP | 2005-05-02 | ESMOLOL HYDROCHLORIDE |
| 3 | ANDA076573_001 | RX | ESMOLOL HYDROCHLORIDE (10MG/ML) | INJECTION | False | AP | 2005-05-02 | ESMOLOL HYDROCHLORIDE |
| 4 | ANDA201126_001 | RX | ESMOLOL HYDROCHLORIDE (10MG/ML) | INJECTION | False | AP | 2015-02-20 | ESMOLOL HYDROCHLORIDE |
| 5 | ANDA205520_001 | RX | ESMOLOL HYDROCHLORIDE (10MG/ML) | INJECTION | False | AP | 2015-07-23 | ESMOLOL HYDROCHLORIDE |
| 6 | NDA019386_003 | discontinued | ESMOLOL HYDROCHLORIDE (10MG/ML) | INJECTION | False | 1988-08-15 | BREVIBLOC | |
| 7 | NDA019386_004 | RX | ESMOLOL HYDROCHLORIDE (1GM/100ML) | INJECTION | True | 2001-02-16 | BREVIBLOC | |
| 8 | NDA019386_005 | RX | ESMOLOL HYDROCHLORIDE (2GM/100ML) | INJECTION | True | 2003-01-27 | BREVIBLOC | |
| 9 | NDA019386_006 | RX | ESMOLOL HYDROCHLORIDE (10MG/ML) | INJECTION | True | AP | 2003-02-25 | BREVIBLOC |
| 10 | NDA019386_007 | discontinued | ESMOLOL HYDROCHLORIDE (20MG/ML) | INJECTION | False | 2003-05-28 | BREVIBLOC |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p6310094 (view patent) | 2021-01-12 | NDA019386 |
| 2 | p6528540 (view patent) | 2021-01-12 | NDA019386 |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 35460df2-18d3-4132-85e6-5289bad4c670 (view SPL) | Esmolol HCL 10 mg/mL Injection 10mL Single Dose Vial | prescription | Human Prescription | General Injecatables & Vaccines, Inc | 2011-04-26 | 2 | 525840017 | |
| 2 | 595cc3d5-1306-4828-aefa-5595219ffd62 (view SPL) | These highlights do not include all the information needed to use BREVIBLOC safely and effectively. See full prescribing information for BREVIBLOC injection.BREVIBLOC (Esmolol Hydrochloride) injection, for intravenous use Initial U.S. Approval: 1986 | prescription | Human Prescription | Baxter Healthcare Corporation | ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE | 2014-04-01 | 7 | 100190055, 100190075, 100190115 |
| 3 | 6dcbdd78-c69d-4d70-81ce-8cb7f7580b48 (view SPL) | These highlights do not include all the information needed to use Esmolol Hydrochloride safely and effectively. See full prescribing information for Esmolol Hydrochloride injection. Esmolol Hydrochloride injection, for intravenous use Initial U.S. Approval: 1986 | prescription | Human Prescription | Cardinal Health | REPACK | 2015-09-24 | 2 | 551542888 |
| 4 | 94f069f9-dd52-4a69-a103-ebdb4294f088 (view SPL) | prescription | Human Prescription | Mylan Institutional Llc | 2012-04-30 | 4 | 674570182 | ||
| 5 | a2e031a3-10ab-40e5-a421-eb54d00c0ac5 (view SPL) | ESMOLOL HYDROCHLORIDE | prescription | Human Prescription | General Injecatables & Vaccines, Inc | 2015-09-10 | 1 | 525840049 | |
| 6 | a70baf53-e38a-4b23-8905-ee284170236d (view SPL) | Esmolol Hydrochloride Injection | prescription | Human Prescription | West-Ward Pharmaceuticals Corp. | ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE | 2007-11-06 | 2 | 006412965 |
| 7 | ac22475d-2d78-469f-9435-b403ac4ee380 (view SPL) | These highlights do not include all the information needed to use ESMOLOL HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for ESMOLOL HYDROCHLORIDE INJECTION. ESMOLOL HYDROCHLORIDE injection, for intravenous useInitial U.S. Approval: 1986 | prescription | Human Prescription | Auromedics Pharma Llc | ANALYSIS, MANUFACTURE | 2015-07-27 | 1 | 551500194 |
| 8 | b0df082a-838f-4556-8399-dd8229c5974a (view SPL) | Esmolol Hydrochloride Injection (10 mg/mL) For Intravenous Use 10 mL Single Dose Vial | prescription | Human Prescription | General Injecatables & Vaccines, Inc | 2015-09-08 | 2 | 525840652 | |
| 9 | c8d2e135-ec31-4eee-bce2-c85e7858c5e1 (view SPL) | Brevibloc (Esmolol Hydrochloride) 10 mg/mL Injection 10 mL Single Dose VialThese highlights do not include all the information needed to use BREVIBLOC safely and effectively. See full prescribing information for BREVIBLOC injection.BREVIBLOC (Esmolol Hydrochloride) injection, for intravenous use Initial U.S. Approval: 1986 | prescription | Human Prescription | General Injecatables & Vaccines, Inc | 2014-03-18 | 3 | 525840115 | |
| 10 | f0a56c07-8f0f-4499-8d00-f13a966bf988 (view SPL) | These highlights do not include all the information needed to use Esmolol Hydrochloride safely and effectively. See full prescribing information for Esmolol Hydrochloride injection. Esmolol Hydrochloride injection, for intravenous use Initial U.S. Approval: 1986 | prescription | Human Prescription | Baxter Healthcare Corporation | ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE | 2014-04-01 | 3 | 100190120 |
| 11 | f1a60c72-a4e3-437d-b472-8d5bffc91273 (view SPL) | Esmolol HCL Injection 10 mg/mL Injection, USP 10 mL Single Dose Vial | prescription | Human Prescription | General Injecatables & Vaccines, Inc | 2011-03-24 | 2 | 525840062 | |
| 12 | fdc9cea8-0eb4-4930-9e1c-d44bfa9346d2 (view SPL) | These highlights do not include all the information needed to use Esmolol Hydrochloride Injection safely and effectively. See full prescribing information for Esmolol Hydrochloride Injection. Esmolol Hydrochloride Injection, for intravenous use Initial U.S. Approval: 1986 | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2013-05-16 | 2 | 633230652 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII