APPLICATION
ANDA078177
TYPE
ANDA
ORIGINAL APPROVAL
2007-04-12
LATEST ACTION
2009-06-02
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
2009-06-02Labeling · Supplement 5AP
2008-09-22Labeling · Supplement 3AP
2007-04-12OriginalAP
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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