APPLICATION
ANDA203173
TYPE
ANDA
ORIGINAL APPROVAL
2015-03-24
LATEST ACTION
2019-08-19
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ACETYLCYSTEINEPrescription
ACETYLCYSTEINE 6GM/30ML (200MG/ML) · INJECTABLE · INTRAVENOUS
Approval history
2019-08-19Labeling · Supplement 1 · standardAP
2019-08-19Labeling · Supplement 2 · standardAP
2015-03-24UNKNOWN · OriginalAP
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.