APPLICATION
ANDA212461
TYPE
ANDA
ORIGINAL APPROVAL
2020-10-05
LATEST ACTION
2024-04-08
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ATROPINE SULFATEPrescription
ATROPINE SULFATE 1MG/10ML (0.1MG/ML) · SOLUTION · INTRAVENOUS
Approval history
2024-04-08Labeling · Supplement 1 · 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.