Is there a generic for Acetylcholine chloride?

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

What is the reference-listed drug for Acetylcholine chloride?

MIOCHOL-E (NDA 020213, BAUSCH AND LOMB) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Acetylcholine chloride are approved?

Acetylcholine chloride is approved in the following dosage form: for solution.

FDA Orange Book · active-ingredient family

Acetylcholine chloride

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

Reference-listed drug:MIOCHOL-E · NDA 020213

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · for solution

Product	Applicant	Application	TE	Approved
MIOCHOL-ERLD	BAUSCH AND LOMB	NDA 020213	—	Sep 22, 1993
MIOCHOLRLD	NOVARTIS	NDA 016211	—	Approved Prior to Jan 1, 1982

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.

Acetylcholine chloride — frequently asked questions

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

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