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: 1 brand, 5 generics; first approved Aug 06, 1985; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 5 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

TENSILONRLD

PAI HOLDINGS PHARMNDA 007959—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—

Abbreviated applications

Generic (ANDA) products (5)

EDROPHONIUM CHLORIDE

HOSPIRAANDA 0401311998

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Discontinued	—

EDROPHONIUM CHLORIDE

WATSON LABSANDA 0400441996

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Discontinued	—

EDROPHONIUM CHLORIDE PRESERVATIVE FREE

WATSON LABSANDA 0400431996

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Discontinued	—

REVERSOL

ORGANON USA INCANDA 0896241988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Discontinued	—

ENLON

PHARMOBEDIENTANDA 0888731985

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Discontinued	—

Orange Book patent file

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.

FDA approval span

Approval history

First approval

Aug 06, 1985

41 yr 6 mo ago

Most recent approval

Feb 24, 1998

28 yr 9 mo ago

Approvals span 1985–1998 across 6 FDA applications.

Brand (NDA) 117%

Generic (ANDA) 583%

Edrophonium chloride — frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Related FDA reference tools

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo