APPLICATION
NDA018897
TYPE
NDA
ORIGINAL APPROVAL
1984-07-20
LATEST ACTION
2020-06-18
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued, Prescription
Products
SODIUM CHLORIDE 14.6% · ReferenceDiscontinued
SODIUM CHLORIDE 50MEQ/20ML (2.5MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS
SODIUM CHLORIDE 14.6% · ReferencePrescription
SODIUM CHLORIDE 100MEQ/40ML (2.5MEQ/ML) · SOLUTION · INTRAVENOUS
SODIUM CHLORIDE 23.4% · ReferencePrescription
SODIUM CHLORIDE 400MEQ/100ML (4MEQ/ML) · SOLUTION · INTRAVENOUS
Approval history
2014-06-12Manufacturing (CMC) · Supplement 28 · standardAP
2014-02-12Manufacturing (CMC) · Supplement 27 · standardAP
2001-06-07Labeling · Supplement 11 · standardAP
2001-02-16Manufacturing (CMC) · Supplement 15 · standardAP
2000-02-09Labeling · Supplement 13 · standardAP
1999-08-31Manufacturing (CMC) · Supplement 14 · standardAP
1999-01-13Manufacturing (CMC) · Supplement 12 · standardAP
1997-01-17Manufacturing (CMC) · Supplement 9 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 10 · standardAP
1992-04-08Labeling · Supplement 7AP
1988-10-21Manufacturing (CMC) · Supplement 6 · standardAP
1987-12-11Manufacturing (CMC) · Supplement 5 · standardAP
1986-09-04Manufacturing (CMC) · Supplement 2 · standardAP
1986-09-04Labeling · Supplement 3AP
1986-07-25Manufacturing (CMC) · Supplement 4 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 1 · standardAP
1984-07-20Type 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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