Is there a generic for Edrophonium chloride?

Yes. The FDA Orange Book lists 5 approved generic (ANDA) applications for Edrophonium chloride, referencing the brand TENSILON. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Edrophonium chloride?

TENSILON (NDA 007959, PAI HOLDINGS PHARM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Edrophonium chloride are approved?

Edrophonium chloride is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Edrophonium chloride

Edrophonium chloride is approved as 1 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:TENSILON · NDA 007959

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
TENSILONRLD×2	PAI HOLDINGS PHARM	NDA 007959	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (5)

Product	Applicant	Application	TE	Approved
EDROPHONIUM CHLORIDE	HOSPIRA	ANDA 040131	—	Feb 24, 1998
EDROPHONIUM CHLORIDE	WATSON LABS	ANDA 040044	—	Mar 20, 1996
EDROPHONIUM CHLORIDE PRESERVATIVE FREE	WATSON LABS	ANDA 040043	—	Mar 20, 1996
REVERSOL	ORGANON USA INC	ANDA 089624	—	May 13, 1988
ENLON	PHARMOBEDIENT	ANDA 088873	—	Aug 06, 1985

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.

Edrophonium chloride — frequently asked questions

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

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