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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216603
Company: AMNEAL

Products on ANDA 216603

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	1GM/100ML	INJECTABLE;INJECTION	Prescription	AP	No	No
ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	2GM/100ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216603

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/13/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216603Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 216603

ESMOLOL HYDROCHLORIDE

INJECTABLE;INJECTION; 1GM/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BREVIBLOC IN PLASTIC CONTAINER	ESMOLOL HYDROCHLORIDE	1GM/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	019386	BAXTER HLTHCARE
ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	1GM/100ML	INJECTABLE;INJECTION	Prescription	No	AP	216603	AMNEAL
ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	1GM/100ML	INJECTABLE;INJECTION	Prescription	No	AP	216244	EUGIA PHARMA
ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	1GM/100ML	INJECTABLE;INJECTION	Prescription	No	AP	214172	HQ SPCLT PHARMA
ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	1GM/100ML	INJECTABLE;INJECTION	Prescription	No	AP	206608	MYLAN LABS LTD
ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	1GM/100ML	INJECTABLE;INJECTION	Prescription	No	AP	207107	SAGENT PHARMS INC

INJECTABLE;INJECTION; 2GM/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER	ESMOLOL HYDROCHLORIDE	2GM/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	019386	BAXTER HLTHCARE
ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	2GM/100ML	INJECTABLE;INJECTION	Prescription	No	AP	216603	AMNEAL
ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	2GM/100ML	INJECTABLE;INJECTION	Prescription	No	AP	216244	EUGIA PHARMA
ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	2GM/100ML	INJECTABLE;INJECTION	Prescription	No	AP	214172	HQ SPCLT PHARMA
ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	2GM/100ML	INJECTABLE;INJECTION	Prescription	No	AP	206608	MYLAN LABS LTD
ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	2GM/100ML	INJECTABLE;INJECTION	Prescription	No	AP	207107	SAGENT PHARMS INC

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