APPLICATION
ANDA207956
TYPE
ANDA
ORIGINAL APPROVAL
2017-05-25
LATEST ACTION
2026-03-11
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
Approval history
2026-03-11Labeling · Supplement 7 · standardAP
2020-06-09Labeling · Supplement 4 · standardAP
2017-05-25UNKNOWN · 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.
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