Is there a generic for Methacholine chloride?

The FDA Orange Book does not currently list an approved generic (ANDA) for Methacholine chloride. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Methacholine chloride?

PROVOCHOLINE (NDA 019193, METHAPHARM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Methacholine chloride are approved?

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

FDA Orange Book · active-ingredient family

Methacholine chloride

Methacholine chloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:PROVOCHOLINE · NDA 019193

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · for solution

Product	Applicant	Application	TE	Approved
PROVOCHOLINERLD×2	METHAPHARM	NDA 019193	—	Oct 31, 1986

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.

Methacholine chloride — frequently asked questions

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

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