Provocholine

Helps diagnose bronchial airway hyperreactivity. NDA 19193, held by Methapharm. Methacholine Chloride.

As of Nov 13, 2026, NDA 19193 (Provocholine), held by Methapharm, was first approved by FDA on Oct 31, 1986, with 14 approved supplements and 0 published complete response letters.

First approved: Oct 31, 1986
Review: Priority
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Provocholine, used in a methacholine challenge test, is indicated for the diagnosis of bronchial airway hyperreactivity in adults and pediatric patients five years of age and older who do not have clinically apparent asthma.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Nov 8, 2019	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 31, 1986	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Provocholine100MG/VIAL · for solution;inhalation	Methacholine Chloride	RxReference drug
Provocholine1600MG/VIAL · for solution;inhalation	Methacholine Chloride	DiscontinuedReference drug

All 15 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 6, 2026	Supplement 32Labeling · Standard review	Approved	Label Letter
Mar 1, 2022	Supplement 26Manufacturing	Approved	Letter Label
Nov 10, 2020	Supplement 24Labeling · Standard review	Approved	Label Letter
Nov 8, 2019	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 29, 2016	Supplement 17Manufacturing	Approved	Label
Jul 28, 2008	Supplement 13Labeling · Standard review	Approved	Label Letter
Mar 8, 2002	Supplement 11Manufacturing · Priority review	Approved	None posted
May 21, 1998	Supplement 9Manufacturing · Priority review	Approved	None posted
Apr 14, 1998	Supplement 8Manufacturing · Priority review	Approved	None posted
Mar 6, 1996	Supplement 6Manufacturing · Priority review	Approved	None posted
Mar 5, 1996	Supplement 7Manufacturing · Priority review	Approved	None posted
Jan 6, 1995	Supplement 3Manufacturing · Priority review	Approved	None posted
Sep 29, 1993	Supplement 4Manufacturing · Priority review	Approved	None posted
Jun 17, 1988	Supplement 2Labeling	Approved	None posted
Oct 31, 1986	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 19193
Drugs@FDA: Overview at FDA
Company: Methapharm Inc

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters