APPLICATION
ANDA076316
TYPE
ANDA
ORIGINAL APPROVAL
2004-10-27
LATEST ACTION
2004-10-27
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
Approval history
2004-10-27OriginalAP
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.