APPLICATION
ANDA205643
TYPE
ANDA
ORIGINAL APPROVAL
2023-11-01
LATEST ACTION
2023-11-01
ROUTE
INHALATION, ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
ACETYLCYSTEINEDiscontinued
ACETYLCYSTEINE 20% · SOLUTION · INHALATION, ORAL
Approval history
2023-11-01UNKNOWN · Original · standardAP
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.