APPLICATION
ANDA208122
TYPE
ANDA
ORIGINAL APPROVAL
2018-07-23
LATEST ACTION
2022-06-10
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERPrescription
SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
Approval history
2022-06-10Manufacturing (CMC) · Supplement 11 · unknownAP
2020-11-30Manufacturing (CMC) · Supplement 6 · unknownAP
2020-11-05Labeling · Supplement 2 · standardAP
2018-07-23UNKNOWN · 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.