← FDA DRUG APPROVALS

FDA NDA · NDA019193

PROVOCHOLINE

methacholine chloride

Sponsor: METHAPHARM

APPLICATION
NDA019193
TYPE
NDA
ORIGINAL APPROVAL
1986-10-31
LATEST ACTION
2026-06-06
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Discontinued, Prescription

Products

PROVOCHOLINE · ReferenceDiscontinued
METHACHOLINE CHLORIDE 1600MG/VIAL · FOR SOLUTION · INHALATION
PROVOCHOLINE · ReferencePrescription
METHACHOLINE CHLORIDE 100MG/VIAL · FOR SOLUTION · INHALATION

Approval history

2026-06-06Labeling · Supplement 32 · standard — Letter ↗AP
2022-03-01Manufacturing (CMC) · Supplement 26 — Letter ↗AP
2020-11-10Labeling · Supplement 24 · standard — Letter ↗AP
2019-11-08Efficacy · Supplement 21 · standard — Label ↗AP
2016-08-29Manufacturing (CMC) · Supplement 17 · unknown — Label ↗AP
2008-07-28Labeling · Supplement 13 · standard — Label ↗AP
2002-03-08Manufacturing (CMC) · Supplement 11 · priorityAP
1998-05-21Manufacturing (CMC) · Supplement 9 · priorityAP
1998-04-14Manufacturing (CMC) · Supplement 8 · priorityAP
1996-03-06Manufacturing (CMC) · Supplement 6 · priorityAP
1996-03-05Manufacturing (CMC) · Supplement 7 · priorityAP
1995-01-06Manufacturing (CMC) · Supplement 3 · priorityAP
1993-09-29Manufacturing (CMC) · Supplement 4 · priorityAP
1988-06-17Labeling · Supplement 2AP
1986-10-31Type 1 - New Molecular Entity · Original · priorityAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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