APPLICATION
NDA019047
TYPE
NDA
ORIGINAL APPROVAL
1984-06-15
LATEST ACTION
2005-08-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PLASMA-LYTE 56 IN PLASTIC CONTAINERDiscontinued
MAGNESIUM ACETATE TETRAHYDRATE 32MG/100ML, POTASSIUM ACETATE 128MG/100ML, SODIUM CHLORIDE 234MG/100ML · INJECTABLE · INJECTION
Approval history
2001-08-14Manufacturing (CMC) · Supplement 21 · standardAP
2001-02-01Labeling · Supplement 20 · standardAP
1999-11-24Manufacturing (CMC) · Supplement 19 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 17 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 15 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 16 · standardAP
1991-10-10Manufacturing (CMC) · Supplement 14 · standardAP
1991-04-29Manufacturing (CMC) · Supplement 12 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 11 · standardAP
1991-02-15Manufacturing (CMC) · Supplement 10 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 9 · standardAP
1987-07-25Manufacturing (CMC) · Supplement 7 · standardAP
1987-05-28Manufacturing (CMC) · Supplement 6 · standardAP
1986-02-27Manufacturing (CMC) · Supplement 4 · standardAP
1985-07-11Manufacturing (CMC) · Supplement 1 · standardAP
1985-04-26Manufacturing (CMC) · Supplement 3 · standardAP
1985-01-26Labeling · Supplement 2 · standardAP
1984-06-15Type 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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