Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208805
Company: AMNEAL PHARMS CO

Products on ANDA 208805

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ETHACRYNIC ACID	ETHACRYNIC ACID	25MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208805

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/08/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 208805

ETHACRYNIC ACID

TABLET;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EDECRIN	ETHACRYNIC ACID	25MG	TABLET;ORAL	Prescription	Yes	AB	016092	BAUSCH
ETHACRYNIC ACID	ETHACRYNIC ACID	25MG	TABLET;ORAL	Prescription	No	AB	211809	AGNITIO
ETHACRYNIC ACID	ETHACRYNIC ACID	25MG	TABLET;ORAL	Prescription	No	AB	208805	AMNEAL PHARMS CO
ETHACRYNIC ACID	ETHACRYNIC ACID	25MG	TABLET;ORAL	Prescription	No	AB	213240	CHARTWELL RX
ETHACRYNIC ACID	ETHACRYNIC ACID	25MG	TABLET;ORAL	Prescription	No	AB	205609	EDENBRIDGE PHARMS
ETHACRYNIC ACID	ETHACRYNIC ACID	25MG	TABLET;ORAL	Prescription	No	AB	211719	LUPIN LTD
ETHACRYNIC ACID	ETHACRYNIC ACID	25MG	TABLET;ORAL	Prescription	No	AB	208501	PAR PHARM INC
ETHACRYNIC ACID	ETHACRYNIC ACID	25MG	TABLET;ORAL	Prescription	No	AB	211232	SCIEGEN PHARMS INC
ETHACRYNIC ACID	ETHACRYNIC ACID	25MG	TABLET;ORAL	Prescription	No	AB	212417	UPSHER SMITH LABS