Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019386
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BREVIBLOC | ESMOLOL HYDROCHLORIDE | 250MG/ML | INJECTABLE; INJECTION | Discontinued | None | No | No |
| BREVIBLOC | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| BREVIBLOC | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| BREVIBLOC | ESMOLOL HYDROCHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER | ESMOLOL HYDROCHLORIDE | 2GM/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| BREVIBLOC IN PLASTIC CONTAINER | ESMOLOL HYDROCHLORIDE | 1GM/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/31/1986 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-386_ Brevibloc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/15/2023 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019386s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019386Orig1s053ltr.pdf | |
| 08/14/2015 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/2015 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/20/2014 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/2012 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019386s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019386Orig1s043ltr.pdf | |
| 08/13/2013 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/06/2007 | SUPPL-39 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019386s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019386s039ltr.pdf | |
| 08/18/2003 | SUPPL-24 | Manufacturing (CMC)-Formulation |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19386scf024ltr.pdf |
| 05/28/2003 | SUPPL-22 | Manufacturing (CMC) |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19386scm022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019386_S022_Brevibloc.pdf |
| 02/25/2003 | SUPPL-21 | Manufacturing (CMC)-Formulation |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19386scf021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/19-386s021.cfm |
| 01/27/2003 | SUPPL-20 | Manufacturing (CMC)-Formulation |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19386scf019,02ltr.pdf |
| 01/27/2003 | SUPPL-19 | Manufacturing (CMC)-Formulation |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19386scf019,02ltr.pdf |
| 02/16/2001 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019386_S018_BREVIBLOC_INJECTION.pdf |
| 01/26/2001 | SUPPL-17 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019386_S017_BREVIBLOC_INJECTION.pdf |
| 01/19/2000 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 02/23/2000 | SUPPL-15 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019386_S015_BREVIBLOC_INJECTION.pdf |
| 10/04/1995 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 01/13/1994 | SUPPL-12 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S012_BREVIBLOC.pdf |
| 11/24/1993 | SUPPL-11 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S011_BREVIBLOC.pdf |
| 07/01/1993 | SUPPL-10 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S010_BREVIBLOC_INJECTION.pdf |
| 10/21/1991 | SUPPL-9 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S009_BREVIBLOC_INJECTION.pdf |
| 12/18/1992 | SUPPL-8 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 05/11/1989 | SUPPL-7 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S007_BREVIBLOC.pdf |
| 08/15/1988 | SUPPL-6 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S004&S006_BREVIBLOC.pdf |
| 05/26/1989 | SUPPL-5 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S005_BREVIBLOC.pdf |
| 08/15/1988 | SUPPL-4 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S004&S006_BREVIBLOC.pdf |
| 12/18/1992 | SUPPL-3 | Efficacy-New Indication |
Label is not available on this site. |
||
| 08/15/1988 | SUPPL-2 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S001&S002_BREVIBLOC_INJ.pdf |
| 08/15/1988 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S001&S002_BREVIBLOC_INJ.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/15/2023 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019386s053lbl.pdf | |
| 12/11/2012 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019386s043lbl.pdf | |
| 11/06/2007 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019386s039lbl.pdf |
BREVIBLOC
INJECTABLE;INJECTION; 10MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BREVIBLOC | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019386 | BAXTER HLTHCARE |
| ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 205520 | EUGIA PHARMA |
| ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 208538 | GLAND PHARMA LTD |
| ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076323 | HIKMA |
| ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076474 | MYLAN INSTITUTIONAL |
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 2GM/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER | ESMOLOL HYDROCHLORIDE | 2GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019386 | BAXTER HLTHCARE |
| ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 2GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 216603 | AMNEAL |
| ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 2GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 216244 | EUGIA PHARMA |
| ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 2GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 214172 | HQ SPCLT PHARMA |
| ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 2GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 206608 | MYLAN LABS LTD |
| ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 2GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 207107 | SAGENT PHARMS INC |
BREVIBLOC IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 1GM/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BREVIBLOC IN PLASTIC CONTAINER | ESMOLOL HYDROCHLORIDE | 1GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019386 | BAXTER HLTHCARE |
| ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 1GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 216603 | AMNEAL |
| ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 1GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 216244 | EUGIA PHARMA |
| ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 1GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 214172 | HQ SPCLT PHARMA |
| ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 1GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 206608 | MYLAN LABS LTD |
| ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 1GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 207107 | SAGENT PHARMS INC |