FDA NDA · NDA018681

LACTATED RINGERS

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

Sponsor: B BRAUN

APPLICATION

NDA018681

TYPE

NDA

ORIGINAL APPROVAL

1982-12-27

LATEST ACTION

2014-09-02

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

2014-09-02Manufacturing (CMC) · Supplement 27 — Label ↗AP

2007-05-31Labeling · Supplement 19AP

2002-08-21Manufacturing (CMC) · Supplement 18 · standardAP

2002-04-10Manufacturing (CMC) · Supplement 17 · standardAP

1998-06-25Manufacturing (CMC) · Supplement 15 · standardAP

1995-04-04Manufacturing (CMC) · Supplement 13 · standardAP

1990-09-11Manufacturing (CMC) · Supplement 12 · standardAP

1988-04-19Manufacturing (CMC) · Supplement 10 · standardAP

1987-03-05Manufacturing (CMC) · Supplement 6 · standardAP

1985-11-13Labeling · Supplement 8AP

1985-07-16Labeling · Supplement 7AP

1985-04-03Manufacturing (CMC) · Supplement 4 · standardAP

1985-03-18Labeling · Supplement 3AP

1985-03-18Manufacturing (CMC) · Supplement 2 · standardAP

1985-01-19Manufacturing (CMC) · Supplement 1 · standardAP

1982-12-27Type 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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