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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216434
Company: GLAND

Products on ANDA 216434

CSV Excel Print

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

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Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216434

Original Approvals or Tentative Approvals

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Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
05/26/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

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Therapeutic Equivalents for ANDA 216434

BUMETANIDE

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

CSV Excel Print

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	218746	ASPIRO
BUMETANIDE	BUMETANIDE	0.25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	216434	GLAND
BUMETANIDE	BUMETANIDE	0.25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	217153	LUPIN LTD
BUMETANIDE	BUMETANIDE	0.25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	215364	MSN
BUMETANIDE	BUMETANIDE	0.25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	219116	QILU PHARM HAINAN
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

Showing 1 to 7 of 7 entries

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