← FDA DRUG APPROVALS

FDA NDA · NDA208437

LONHALA MAGNAIR KIT

Sponsor: SUMITOMO PHARMA AM

APPLICATION
NDA208437
TYPE
NDA
ORIGINAL APPROVAL
2017-12-05
LATEST ACTION
2019-06-24
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

LONHALA MAGNAIR KIT · ReferenceDiscontinued
GLYCOPYRROLATE 25MCG/ML · SOLUTION · INHALATION

Approval history

2019-06-24Labeling · Supplement 3 · standard — Letter ↗AP
2017-12-05Type 3 - New Dosage Form and Type 4 - New Combination · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →