FDA NDA · NDA019416

LACTATED RINGERS

sodium chloride, sodium lactate, potassium chloride, and calcium chloride

Sponsor: OTSUKA ICU MEDCL

APPLICATION

NDA019416

TYPE

NDA

ORIGINAL APPROVAL

1986-01-17

LATEST ACTION

2014-08-15

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

2014-08-15Manufacturing (CMC) · Supplement 32 · standardAP

1999-12-13Labeling · Supplement 15AP

1997-08-21Manufacturing (CMC) · Supplement 17 · standardAP

1997-06-11Manufacturing (CMC) · Supplement 16 · standardAP

1996-08-27Manufacturing (CMC) · Supplement 14 · standardAP

1992-01-28Manufacturing (CMC) · Supplement 12 · standardAP

1991-09-10Manufacturing (CMC) · Supplement 11 · standardAP

1990-02-22Manufacturing (CMC) · Supplement 8 · standardAP

1990-01-11Manufacturing (CMC) · Supplement 9 · standardAP

1989-06-22Manufacturing (CMC) · Supplement 4 · standardAP

1989-06-14Manufacturing (CMC) · Supplement 7 · standardAP

1986-11-26Manufacturing (CMC) · Supplement 3 · standardAP

1986-08-08Manufacturing (CMC) · Supplement 2 · standardAP

1986-05-13Manufacturing (CMC) · Supplement 1 · standardAP

1986-01-17Type 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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