FDA approved the original new drug application for BREVIBLOC on December 31, 1986, sponsored by BAXTER HLTHCARE. FDA classed that submission a new molecular entity, which makes it the first approval of esmolol hydrochloride in any product. FDA marks 3 of the application’s 6 products discontinued and the other 3 still marketed. FDA has approved 2 efficacy supplements on the application since, the most recent on December 18, 1992.
- Application
- NDA019386
- Sponsor
- BAXTER HLTHCARE
- Original approval
- Review
- priority review
- Submission class
- Type 1 - New Molecular Entity
- Active ingredient
- esmolol hydrochloride
Browse every approval whose brand starts with B, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| esmolol hydrochloride 10MG/ML | INJECTABLE | INJECTION | Prescription |
| esmolol hydrochloride 1GM/100ML | INJECTABLE | INJECTION | Prescription |
| esmolol hydrochloride 250MG/ML | INJECTABLE | INJECTION | Discontinued |
| esmolol hydrochloride 20MG/ML | INJECTABLE | INJECTION | Discontinued |
| esmolol hydrochloride 2GM/100ML | INJECTABLE | INJECTION | Prescription |
| esmolol hydrochloride 10MG/ML | INJECTABLE | INJECTION | Discontinued |
What “discontinued” means in FDA’s record
Drugs@FDA marks a product discontinued when it was never marketed, when it has been taken off the market, when it is made only for export, when it is made for military use, or when its approval was withdrawn for a reason other than safety or effectiveness. The record does not say which of those applies to a given product. The word on its own is not evidence that FDA found the drug unsafe.
Source: FDA, Drugs@FDA glossary of terms, under “Discontinued Drug Product”.
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
| Approved | Supplement | Review |
|---|---|---|
| S-3 | — | |
| S-8 | — |
FDA records other approved supplements on this application, by the class code it assigns them: Manufacturing (CMC) 18 · Labeling 10. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
Other approvals to BAXTER HLTHCARE
- December 24, 2008NEXTERONENDA022325
- August 5, 2008CEFEPIME IN PLASTIC CONTAINERNDA050817
- March 21, 2002MESNEXNDA020855
- August 26, 1998PROSOL 20% SULFITE FREE IN PLASTIC CONTAINERNDA020849
- September 29, 1997CLINIMIX 8/14 SULFITE FREE IN DEXTROSE 14% IN PLASTIC CONTAINERNDA020734
- March 26, 1997CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINERNDA020678
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