Viewing data from:

ESMOLOL HYDROCHLORIDE

ANDA

ESMOLOL HYDROCHLORIDE | A206608 | MYLAN LABORATORIES LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: BREVIBLOC(TE code: AP)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
BAXTER HEALTHCARE CORPORATION et al v. AGILA SPECIALTIES PRIVATE LIMITED et al 1:2014cv07094 2 patentsANDA 206608esmolol hydrochloride	D.N.J.	2014-11-12	Terminated 2016-04-20	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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
Jul 16, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 1GM/100ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jun 8, 2018

No patent or exclusivity listings for this strength.

#002 — 2GM/100ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jun 8, 2018