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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209724
Company: AMNEAL PHARMS CO

Products on ANDA 209724

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUMETANIDE	BUMETANIDE	0.5MG	TABLET;ORAL	Prescription	AB	No	No
BUMETANIDE	BUMETANIDE	1MG	TABLET;ORAL	Prescription	AB	No	No
BUMETANIDE	BUMETANIDE	2MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209724

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/18/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 209724

BUMETANIDE

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUMETANIDE	BUMETANIDE	0.5MG	TABLET;ORAL	Prescription	No	AB	209724	AMNEAL PHARMS CO
BUMETANIDE	BUMETANIDE	0.5MG	TABLET;ORAL	Prescription	No	AB	074225	HERITAGE PHARMA
BUMETANIDE	BUMETANIDE	0.5MG	TABLET;ORAL	Prescription	No	AB	074700	SANDOZ
BUMETANIDE	BUMETANIDE	0.5MG	TABLET;ORAL	Prescription	No	AB	213458	TARO
BUMETANIDE	BUMETANIDE	0.5MG	TABLET;ORAL	Prescription	No	AB	209916	UPSHER SMITH LABS
BUMETANIDE	BUMETANIDE	0.5MG	TABLET;ORAL	Prescription	No	AB	202900	ZYDUS PHARMS
BUMEX	BUMETANIDE	0.5MG	TABLET;ORAL	Prescription	Yes	AB	018225	VALIDUS PHARMS

TABLET;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUMETANIDE	BUMETANIDE	1MG	TABLET;ORAL	Prescription	No	AB	209724	AMNEAL PHARMS CO
BUMETANIDE	BUMETANIDE	1MG	TABLET;ORAL	Prescription	No	AB	074225	HERITAGE PHARMA
BUMETANIDE	BUMETANIDE	1MG	TABLET;ORAL	Prescription	No	AB	074700	SANDOZ
BUMETANIDE	BUMETANIDE	1MG	TABLET;ORAL	Prescription	No	AB	213458	TARO
BUMETANIDE	BUMETANIDE	1MG	TABLET;ORAL	Prescription	No	AB	209916	UPSHER SMITH LABS
BUMETANIDE	BUMETANIDE	1MG	TABLET;ORAL	Prescription	No	AB	202900	ZYDUS PHARMS
BUMEX	BUMETANIDE	1MG	TABLET;ORAL	Prescription	Yes	AB	018225	VALIDUS PHARMS

TABLET;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUMETANIDE	BUMETANIDE	2MG	TABLET;ORAL	Prescription	No	AB	209724	AMNEAL PHARMS CO
BUMETANIDE	BUMETANIDE	2MG	TABLET;ORAL	Prescription	No	AB	074225	HERITAGE PHARMA
BUMETANIDE	BUMETANIDE	2MG	TABLET;ORAL	Prescription	No	AB	074700	SANDOZ
BUMETANIDE	BUMETANIDE	2MG	TABLET;ORAL	Prescription	No	AB	213458	TARO
BUMETANIDE	BUMETANIDE	2MG	TABLET;ORAL	Prescription	No	AB	209916	UPSHER SMITH LABS
BUMETANIDE	BUMETANIDE	2MG	TABLET;ORAL	Prescription	No	AB	202900	ZYDUS PHARMS
BUMEX	BUMETANIDE	2MG	TABLET;ORAL	Prescription	Yes	AB	018225	VALIDUS PHARMS

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