Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208538
Company: GLAND PHARMA LTD

Products on ANDA 208538

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 208538

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/14/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/10/2023	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208538

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