Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205520
Company: EUGIA PHARMA

Products on ANDA 205520

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205520

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/23/2015	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205520Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 205520

ESMOLOL HYDROCHLORIDE

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