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FDA NDA · NDA018895

TPN ELECTROLYTES

sodium chloride, calcium chloride, potassium chloride, magnesium chloride, and sodium acetate anhydrous

Sponsor: HOSPIRA

APPLICATION
NDA018895
TYPE
NDA
ORIGINAL APPROVAL
1984-07-20
LATEST ACTION
2014-06-12
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

TPN ELECTROLYTES IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE 16.5MG/ML, MAGNESIUM CHLORIDE 25.4MG/ML, POTASSIUM CHLORIDE 74.6MG/ML, SODIUM ACETATE 121MG/ML, SODIUM CHLORIDE 16.1MG/ML · INJECTABLE · INJECTION

Approval history

2014-06-12Manufacturing (CMC) · Supplement 24 · standardAP
2003-04-14Manufacturing (CMC) · Supplement 13 · standard — Letter ↗AP
2001-02-16Manufacturing (CMC) · Supplement 11 · standardAP
2000-02-09Labeling · Supplement 9 · standardAP
1999-08-31Manufacturing (CMC) · Supplement 10 · standardAP
1999-01-22Manufacturing (CMC) · Supplement 8 · standardAP
1997-01-17Manufacturing (CMC) · Supplement 6 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 7 · standardAP
1987-12-11Manufacturing (CMC) · Supplement 4 · standardAP
1986-07-24Manufacturing (CMC) · Supplement 3 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 2 · standardAP
1985-05-14Manufacturing (CMC) · Supplement 1 · standardAP
1984-07-20Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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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