APPLICATION
NDA018803
TYPE
NDA
ORIGINAL APPROVAL
1982-10-29
LATEST ACTION
2015-01-26
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued, Prescription
Products
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferenceDiscontinued
SODIUM CHLORIDE 45MG/5ML (9MG/ML) · SOLUTION · INJECTION
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferenceDiscontinued
SODIUM CHLORIDE 18MG/2ML (9MG/ML) · SOLUTION · INJECTION
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferencePrescription
SODIUM CHLORIDE 180MG/20ML (9MG/ML) · SOLUTION · INJECTION
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferenceDiscontinued
SODIUM CHLORIDE 27MG/3ML (9MG/ML) · SOLUTION · INJECTION
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferencePrescription
SODIUM CHLORIDE 450MG/50ML (9MG/ML) · SOLUTION · INJECTION
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferencePrescription
SODIUM CHLORIDE 90MG/10ML (9MG/ML) · SOLUTION · INJECTION
Approval history
2015-01-26Manufacturing (CMC) · Supplement 24 · standardAP
2014-06-12Manufacturing (CMC) · Supplement 28 · standardAP
2014-02-12Manufacturing (CMC) · Supplement 27 · standardAP
2001-09-12Labeling · Supplement 12 · standardAP
2001-02-16Manufacturing (CMC) · Supplement 14 · standardAP
1999-08-31Manufacturing (CMC) · Supplement 13 · standardAP
1997-01-17Manufacturing (CMC) · Supplement 10 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 11 · standardAP
1989-02-10Labeling · Supplement 7AP
1988-03-24Labeling · Supplement 8AP
1986-02-25Manufacturing (CMC) · Supplement 4 · standardAP
1985-03-15Manufacturing (CMC) · Supplement 5 · standardAP
1984-10-22Manufacturing (CMC) · Supplement 6 · standardAP
1984-06-14Manufacturing (CMC) · Supplement 2 · standardAP
1984-01-25Manufacturing (CMC) · Supplement 1 · standardAP
1984-01-17Manufacturing (CMC) · Supplement 3 · standardAP
1982-10-29Type 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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