Is there a generic for Atropine sulfate; edrophonium chloride?

The FDA Orange Book does not currently list an approved generic (ANDA) for Atropine sulfate; edrophonium chloride. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Atropine sulfate; edrophonium chloride?

ENLON-PLUS (NDA 019678, PHARMOBEDIENT) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Atropine sulfate; edrophonium chloride are approved?

Atropine sulfate; edrophonium chloride is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Atropine sulfate; edrophonium chloride

Atropine sulfate; edrophonium chloride is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:ENLON-PLUS · NDA 019678

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
ENLON-PLUSRLD	PHARMOBEDIENT	NDA 019678	—	Nov 06, 1991
ENLON-PLUS	PHARMOBEDIENT	NDA 019677	—	Nov 06, 1991

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.

Atropine sulfate; 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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