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FDA NDA · NDA019933
LACTATED RINGER'S IN PLASTIC CONTAINER
Sponsor: BAXTER HLTHCARE
APPLICATION
NDA019933
TYPE
NDA
ORIGINAL APPROVAL
1989-08-29
LATEST ACTION
2007-06-15
ROUTE
IRRIGATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
LACTATED RINGER'S IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 20MG/100ML, POTASSIUM CHLORIDE 30MG/100ML, SODIUM CHLORIDE 600MG/100ML, SODIUM LACTATE 310MG/100ML · SOLUTION · IRRIGATION
Approval history
2007-06-15Manufacturing (CMC) · Supplement 10AP
2001-08-14Manufacturing (CMC) · Supplement 8 · standardAP
2000-12-07Labeling · Supplement 6 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 4 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 5 · standardAP
1993-10-05Manufacturing (CMC) · Supplement 2 · standardAP
1991-04-26Manufacturing (CMC) · Supplement 3 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 1 · standardAP
1989-08-29Type 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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