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FDA NDA · NDA018921
LACTATED RINGERS
sodium chloride, soldium lactate, potassium chloride and calcium chloride
Sponsor: BAXTER HLTHCARE
APPLICATION
NDA018921
TYPE
NDA
ORIGINAL APPROVAL
1984-04-03
LATEST ACTION
2015-09-29
ROUTE
IRRIGATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
LACTATED RINGER'S IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE 20MG/100ML, POTASSIUM CHLORIDE 30MG/100ML, SODIUM CHLORIDE 600MG/100ML, SODIUM LACTATE 310MG/100ML · SOLUTION · IRRIGATION
Approval history
2014-09-30Manufacturing (CMC) · Supplement 34 · standardAP
2001-08-29Manufacturing (CMC) · Supplement 22 · standardAP
2000-01-28Manufacturing (CMC) · Supplement 21 · standardAP
1999-05-26Labeling · Supplement 20AP
1997-04-29Manufacturing (CMC) · Supplement 19 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 17 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 18 · standardAP
1993-12-08Manufacturing (CMC) · Supplement 15 · standardAP
1991-05-08Labeling · Supplement 13AP
1991-03-26Manufacturing (CMC) · Supplement 11 · standardAP
1991-02-15Manufacturing (CMC) · Supplement 10 · standardAP
1991-01-22Manufacturing (CMC) · Supplement 12 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 9 · standardAP
1989-01-12Manufacturing (CMC) · Supplement 8 · standardAP
1987-07-25Manufacturing (CMC) · Supplement 6 · standardAP
1987-05-28Manufacturing (CMC) · Supplement 5 · standardAP
1986-02-27Manufacturing (CMC) · Supplement 4 · standardAP
1985-06-13Manufacturing (CMC) · Supplement 1 · standardAP
1985-04-26Manufacturing (CMC) · Supplement 3 · standardAP
1984-04-03Type 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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