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ESMOLOL HYDROCHLORIDE

ANDA

ESMOLOL HYDROCHLORIDE | A076323 | HIKMA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: BREVIBLOC(TE code: AP)

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Bedford Laboratories - Citizen Petition FDA-2008-P-0284 · 6 docket documents Bedford Laboratories filed this citizen petition requesting that the FDA determine whether Baxter Healthcare's discontinuation of Brevibloc Injection (esmolol hydrochloride, NDA 19-386) was due to safety or efficacy reasons. Bedford's tentatively approved ANDA 76-326 for esmolol hydrochloride concen	505(q)	2008-05-09	Open	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain5 active DMFs1 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

DELMAR CHEMICALS INCESMOLOL HYDROCHLORIDE

DMF 44751982

FINORGA SASESMOLOL HYDROCHLORIDE

DMF 68681987

TARO PHARMACEUTICAL INDUSTRIES LTDESMOLOL HYDROCHLORIDE

DMF 168632003

MSN LABORATORIES PRIVATE LTDESMOLOL HYDROCHLORIDE USP [ROUTE CODE-"EH"]

DMF 260242012

GLOBAL CALCIUM PRIVATE LTDESMOLOL HYDROCHLORIDE USP

DMF 368772023

GANES CHEMICALS INC PENNSVILLE DIVInactiveESMOLOL HYDROCHLORIDE

DMF 51261983

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 11, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Aug 10, 2004

No patent or exclusivity listings for this strength.