APPLICATION
NDA019631
TYPE
NDA
ORIGINAL APPROVAL
1988-02-24
LATEST ACTION
2014-08-22
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, SODIUM CHLORIDE 110MG/100ML · INJECTABLE · INJECTION
DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINERPrescription
DEXTROSE 10GM/100ML, SODIUM CHLORIDE 200MG/100ML · INJECTABLE · INJECTION
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERPrescription
DEXTROSE 2.5GM/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINERPrescription
DEXTROSE 2.5GM/100ML, SODIUM CHLORIDE 200MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
DEXTROSE 10GM/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, SODIUM CHLORIDE 200MG/100ML · INJECTABLE · INJECTION
DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINERPrescription
DEXTROSE 10GM/100ML, SODIUM CHLORIDE 330MG/100ML · INJECTABLE · INJECTION
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
DEXTROSE 2.5GM/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINERPrescription
DEXTROSE 10GM/100ML, SODIUM CHLORIDE 110MG/100ML · INJECTABLE · INJECTION
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINERPrescription
DEXTROSE 2.5GM/100ML, SODIUM CHLORIDE 330MG/100ML · INJECTABLE · INJECTION
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINERPrescription
DEXTROSE 2.5GM/100ML, SODIUM CHLORIDE 110MG/100ML · INJECTABLE · INJECTION
DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERPrescription
DEXTROSE 3.3GM/100ML, SODIUM CHLORIDE 300MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, SODIUM CHLORIDE 330MG/100ML · INJECTABLE · INJECTION
DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERPrescription
DEXTROSE 10GM/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
Approval history
2014-08-22Manufacturing (CMC) · Supplement 31 · standardAP
2014-01-24Manufacturing (CMC) · Supplement 34 · standardAP
2002-07-23Manufacturing (CMC) · Supplement 22 · standardAP
2002-03-08Manufacturing (CMC) · Supplement 20 · standardAP
2001-03-12Manufacturing (CMC) · Supplement 19 · standardAP
2000-04-11Manufacturing (CMC) · Supplement 18 · standardAP
1998-09-25Manufacturing (CMC) · Supplement 17 · standardAP
1995-03-17Manufacturing (CMC) · Supplement 16 · standardAP
1994-12-19Manufacturing (CMC) · Supplement 15 · standardAP
1993-07-21Manufacturing (CMC) · Supplement 14 · standardAP
1992-12-29Manufacturing (CMC) · Supplement 13 · standardAP
1991-08-29Manufacturing (CMC) · Supplement 11 · standardAP
1990-09-18Manufacturing (CMC) · Supplement 10 · standardAP
1990-04-13Manufacturing (CMC) · Supplement 8 · standardAP
1990-01-19Labeling · Supplement 9AP
1990-01-19Manufacturing (CMC) · Supplement 6 · standardAP
1989-11-21Manufacturing (CMC) · Supplement 4 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 7 · standardAP
1989-05-05Manufacturing (CMC) · Supplement 5 · standardAP
1988-12-21Manufacturing (CMC) · Supplement 3 · standardAP
1988-08-25Manufacturing (CMC) · Supplement 2 · standardAP
1988-03-25Labeling · Supplement 1AP
1988-02-24Type 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.