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FDA NDA · NDA019217
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor: ICU MEDICAL INC
APPLICATION
NDA019217
TYPE
NDA
ORIGINAL APPROVAL
1984-07-13
LATEST ACTION
2003-12-05
ROUTE
INJECTION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferenceDiscontinued
SODIUM CHLORIDE 90MG/10ML (9MG/ML) · SOLUTION · INJECTION
SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE · ReferenceDiscontinued
SODIUM CHLORIDE 90MG/10ML (9MG/ML) · SOLUTION · INJECTION
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferenceDiscontinued
SODIUM CHLORIDE 360MG/40ML (9MG/ML) · SOLUTION · INJECTION
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferenceDiscontinued
SODIUM CHLORIDE 45MG/5ML (9MG/ML) · SOLUTION · INJECTION
Approval history
1999-04-01Manufacturing (CMC) · Supplement 6 · standardAP
1999-01-22Manufacturing (CMC) · Supplement 5 · standardAP
1998-11-18Manufacturing (CMC) · Supplement 4 · standardAP
1994-03-25Manufacturing (CMC) · Supplement 2 · standardAP
1984-07-13Type 5 - New Formulation or New Manufacturer · 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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