Is there a generic for Ethacrynate sodium?

Yes. The FDA Orange Book lists 4 approved generic (ANDA) applications for Ethacrynate sodium, referencing the brand EDECRIN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ethacrynate sodium?

EDECRIN (NDA 016093, BAUSCH) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Ethacrynate sodium are approved?

Ethacrynate sodium is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Ethacrynate sodium

Ethacrynate sodium is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:EDECRIN · NDA 016093

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
EDECRINRLD	BAUSCH	NDA 016093	AP	Approved Prior to Jan 1, 1982

Generic (ANDA) products (4)

Product	Applicant	Application	TE	Approved
ETHACRYNATE SODIUM	STERIMAX	ANDA 208663	AP	Jun 09, 2020
ETHACRYNATE SODIUM	ZYDUS PHARMS	ANDA 207758	AP	Nov 17, 2017
ETHACRYNATE SODIUM	MYLAN INSTITUTIONAL	ANDA 204634	—	Aug 23, 2016
ETHACRYNATE SODIUM	PH HEALTH	ANDA 205473	AP	Jul 29, 2015

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Ethacrynate sodium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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