Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205473
Company: ENDO OPERATIONS

Products on ANDA 205473

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ETHACRYNATE SODIUM	ETHACRYNATE SODIUM	EQ 50MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205473

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/29/2015	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205473Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 205473

ETHACRYNATE SODIUM

INJECTABLE;INJECTION; EQ 50MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EDECRIN	ETHACRYNATE SODIUM	EQ 50MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	016093	BAUSCH
ETHACRYNATE SODIUM	ETHACRYNATE SODIUM	EQ 50MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	205473	ENDO OPERATIONS
ETHACRYNATE SODIUM	ETHACRYNATE SODIUM	EQ 50MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	204634	MYLAN INSTITUTIONAL
ETHACRYNATE SODIUM	ETHACRYNATE SODIUM	EQ 50MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	208663	STERIMAX
ETHACRYNATE SODIUM	ETHACRYNATE SODIUM	EQ 50MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	207758	ZYDUS PHARMS