Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207758
Company: ZYDUS PHARMS

Products on ANDA 207758

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 207758

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/17/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 207758

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	204634	MYLAN INSTITUTIONAL
ETHACRYNATE SODIUM	ETHACRYNATE SODIUM	EQ 50MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	205473	PAR STERILE PRODUCTS
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