FDA NDA · NDA018494

LACTATED RINGERS

sodium chloride, sodium lactate, potassium chloride, calcium chloride

Sponsor: BAXTER HLTHCARE

APPLICATION

NDA018494

TYPE

NDA

ORIGINAL APPROVAL

1982-02-19

LATEST ACTION

2014-09-30

ROUTE

IRRIGATION

DOSAGE FORM

SOLUTION

MARKETING STATUS

Prescription

Products

LACTATED RINGER'S IN PLASTIC CONTAINERPrescription

CALCIUM CHLORIDE 20MG/100ML, POTASSIUM CHLORIDE 30MG/100ML, SODIUM CHLORIDE 600MG/100ML, SODIUM LACTATE 310MG/100ML · SOLUTION · IRRIGATION

2014-09-30Manufacturing (CMC) · Supplement 26 · standardAP

2014-09-26Manufacturing (CMC) · Supplement 27 · standardAP

2013-04-26Manufacturing (CMC) · Supplement 25 · standardAP

1994-09-30Manufacturing (CMC) · Supplement 14 · standardAP

1993-09-14Manufacturing (CMC) · Supplement 15 · standardAP

1991-11-14Manufacturing (CMC) · Supplement 11 · standardAP

1991-03-26Manufacturing (CMC) · Supplement 12 · standardAP

1991-01-10Manufacturing (CMC) · Supplement 13 · standardAP

1989-07-26Manufacturing (CMC) · Supplement 10 · standardAP

1986-10-30Manufacturing (CMC) · Supplement 9 · standardAP

1985-06-26Labeling · Supplement 7AP

1985-01-24Manufacturing (CMC) · Supplement 3 · standardAP

1984-02-28Manufacturing (CMC) · Supplement 5 · standardAP

1982-05-07Manufacturing (CMC) · Supplement 1 · standardAP

1982-02-19Type 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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