APPLICATION
NDA019022
TYPE
NDA
ORIGINAL APPROVAL
1983-11-01
LATEST ACTION
2018-09-14
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER · ReferencePrescription
SODIUM CHLORIDE 3GM/100ML · INJECTABLE · INJECTION
SODIUM CHLORIDE 5% IN PLASTIC CONTAINER · ReferencePrescription
SODIUM CHLORIDE 5GM/100ML · INJECTABLE · INJECTION
Approval history
2014-06-06Manufacturing (CMC) · Supplement 27 · standardAP
2001-08-14Manufacturing (CMC) · Supplement 19 · standardAP
1999-11-24Manufacturing (CMC) · Supplement 18 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 16 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 14 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 15 · standardAP
1991-04-29Manufacturing (CMC) · Supplement 12 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 11 · standardAP
1991-02-15Manufacturing (CMC) · Supplement 9 · standardAP
1990-05-24Manufacturing (CMC) · Supplement 10 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 8 · standardAP
1987-05-28Manufacturing (CMC) · Supplement 6 · standardAP
1985-06-13Manufacturing (CMC) · Supplement 3 · standardAP
1985-04-26Manufacturing (CMC) · Supplement 5 · standardAP
1985-01-26Labeling · Supplement 4AP
1984-12-06Manufacturing (CMC) · Supplement 1 · standardAP
1984-09-22Manufacturing (CMC) · Supplement 2 · standardAP
1983-11-01Type 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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