APPLICATION
NDA019635
TYPE
NDA
ORIGINAL APPROVAL
1988-03-09
LATEST ACTION
2016-04-26
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE, SOLUTION
MARKETING STATUS
Prescription
Products
SODIUM CHLORIDE 5% IN PLASTIC CONTAINERPrescription
SODIUM CHLORIDE 5GM/100ML · INJECTABLE · INJECTION
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferencePrescription
SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
SODIUM CHLORIDE 0.9% · ReferencePrescription
SODIUM CHLORIDE 90MG/10ML (9MG/ML) · SOLUTION · INJECTION
SODIUM CHLORIDE 3% IN PLASTIC CONTAINERPrescription
SODIUM CHLORIDE 3GM/100ML · INJECTABLE · INJECTION
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER · ReferencePrescription
SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
Approval history
2016-04-26Manufacturing (CMC) · Supplement 41 · standardAP
2015-09-15Manufacturing (CMC) · Supplement 38 · standardAP
2015-07-20Manufacturing (CMC) · Supplement 37 · standardAP
2015-04-07Manufacturing (CMC) · Supplement 36 · standardAP
2004-02-04Labeling · Supplement 22AP
2004-02-04Labeling · Supplement 23AP
2003-06-13Labeling · Supplement 21AP
2002-07-01Manufacturing (CMC) · Supplement 20 · standardAP
2002-04-15Manufacturing (CMC) · Supplement 18 · standardAP
2000-12-07Manufacturing (CMC) · Supplement 17 · standardAP
2000-05-15Manufacturing (CMC) · Supplement 16 · standardAP
1998-08-21Manufacturing (CMC) · Supplement 15 · standardAP
1993-07-21Manufacturing (CMC) · Supplement 12 · standardAP
1993-07-07Manufacturing (CMC) · Supplement 14 · standardAP
1993-04-26Manufacturing (CMC) · Supplement 13 · standardAP
1992-12-29Manufacturing (CMC) · Supplement 11 · standardAP
1991-08-29Manufacturing (CMC) · Supplement 9 · standardAP
1990-09-18Manufacturing (CMC) · Supplement 8 · standardAP
1990-04-13Manufacturing (CMC) · Supplement 7 · standardAP
1989-11-21Manufacturing (CMC) · Supplement 4 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 6 · standardAP
1989-05-05Manufacturing (CMC) · Supplement 5 · standardAP
1988-12-21Manufacturing (CMC) · Supplement 3 · standardAP
1988-08-25Manufacturing (CMC) · Supplement 2 · standardAP
1988-04-04Labeling · Supplement 1AP
1988-03-09Type 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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