← FDA DRUG APPROVALS
FDA NDA · NDA018892
SODIUM PHOSPHATES
sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic, anhydrous
Sponsor: HOSPIRA
APPLICATION
NDA018892
TYPE
NDA
ORIGINAL APPROVAL
1983-05-10
LATEST ACTION
2023-11-30
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
SODIUM PHOSPHATES IN PLASTIC CONTAINER · ReferencePrescription
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 4.02GM/15ML, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 4.14GM/15ML (268MG/ML · SOLUTION · INTRAVENOUS
Approval history
2015-01-12Manufacturing (CMC) · Supplement 31 · standardAP
2014-06-12Manufacturing (CMC) · Supplement 30 · standardAP
2001-02-16Manufacturing (CMC) · Supplement 20 · standardAP
2000-06-16Labeling · Supplement 18 · standardAP
1999-08-31Manufacturing (CMC) · Supplement 19 · standardAP
1999-01-22Manufacturing (CMC) · Supplement 17 · standardAP
1997-11-19Labeling · Supplement 16 · standardAP
1997-01-17Manufacturing (CMC) · Supplement 14 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 15 · standardAP
1989-07-18Manufacturing (CMC) · Supplement 12 · standardAP
1988-10-21Manufacturing (CMC) · Supplement 11 · standardAP
1987-12-11Manufacturing (CMC) · Supplement 9 · standardAP
1987-08-26Labeling · Supplement 10AP
1986-10-21Manufacturing (CMC) · Supplement 8 · standardAP
1986-07-24Manufacturing (CMC) · Supplement 7 · standardAP
1985-03-15Manufacturing (CMC) · Supplement 4 · standardAP
1984-10-22Manufacturing (CMC) · Supplement 5 · standardAP
1984-01-17Manufacturing (CMC) · Supplement 3 · standardAP
1983-10-24Labeling · Supplement 2AP
1983-05-10Type 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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