APPLICATION
NDA202049
TYPE
NDA
ORIGINAL APPROVAL
2020-10-30
LATEST ACTION
2020-10-30
ROUTE
INHALATION
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
BRONCHITOL · ReferencePrescription
MANNITOL 40MG · POWDER · INHALATION
Approval history
2020-10-30Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated · Original · standard — Label ↗AP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.