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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215364
Company: MSN

Products on ANDA 215364

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUMETANIDE	BUMETANIDE	0.25MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215364

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/04/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215364

BUMETANIDE

INJECTABLE;INJECTION; 0.25MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUMETANIDE	BUMETANIDE	0.25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	216434	GLAND PHARMA LTD
BUMETANIDE	BUMETANIDE	0.25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	074332	HOSPIRA
BUMETANIDE	BUMETANIDE	0.25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	215364	MSN
BUMETANIDE	BUMETANIDE	0.25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	074441	SAGENT
BUMETANIDE	BUMETANIDE	0.25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	079196	WEST-WARD PHARMS INT

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