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FDA NDA · NDA017641
LACTATED RINGERS
sodium chloride, sodium lactate, potassium chloride, and calcium chloride
Sponsor: OTSUKA ICU MEDCL
APPLICATION
NDA017641
TYPE
NDA
ORIGINAL APPROVAL
1976-01-26
LATEST ACTION
2016-06-14
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
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 · INJECTABLE · INJECTION
Approval history
2016-06-14Manufacturing (CMC) · Supplement 163 · standardAP
2014-09-17Manufacturing (CMC) · Supplement 150 · standardAP
2014-09-08Manufacturing (CMC) · Supplement 159 · standardAP
2006-04-10Labeling · Supplement 131AP
1999-10-28Labeling · Supplement 124AP
1999-10-13Labeling · Supplement 120AP
1998-12-01Manufacturing (CMC) · Supplement 123 · standardAP
1997-08-21Manufacturing (CMC) · Supplement 122 · standardAP
1997-06-11Manufacturing (CMC) · Supplement 121 · standardAP
1997-03-28Manufacturing (CMC) · Supplement 119 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 116 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 115 · standardAP
1996-08-06Manufacturing (CMC) · Supplement 118 · standardAP
1996-03-04Manufacturing (CMC) · Supplement 117 · standardAP
1995-08-14Manufacturing (CMC) · Supplement 113 · standardAP
1992-01-28Manufacturing (CMC) · Supplement 109 · standardAP
1991-09-10Manufacturing (CMC) · Supplement 108 · standardAP
1991-08-30Manufacturing (CMC) · Supplement 110 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 105 · standardAP
1990-01-11Manufacturing (CMC) · Supplement 106 · standardAP
1989-06-22Manufacturing (CMC) · Supplement 76 · standardAP
1987-07-30Manufacturing (CMC) · Supplement 102 · standardAP
1986-11-26Manufacturing (CMC) · Supplement 101 · standardAP
1986-08-08Manufacturing (CMC) · Supplement 100 · standardAP
1986-02-25Manufacturing (CMC) · Supplement 77 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 98 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 93 · standardAP
1985-12-06Manufacturing (CMC) · Supplement 99 · standardAP
1985-11-29Labeling · Supplement 80AP
1985-11-29Manufacturing (CMC) · Supplement 79 · standardAP
1985-10-29Manufacturing (CMC) · Supplement 78 · standardAP
1985-10-26Labeling · Supplement 89AP
1985-10-26Manufacturing (CMC) · Supplement 87 · standardAP
1985-09-26Manufacturing (CMC) · Supplement 82 · standardAP
1985-08-27Manufacturing (CMC) · Supplement 90 · standardAP
1985-06-10Manufacturing (CMC) · Supplement 95 · standardAP
1985-05-03Manufacturing (CMC) · Supplement 88 · standardAP
1985-03-15Manufacturing (CMC) · Supplement 71 · standardAP
1984-11-09Manufacturing (CMC) · Supplement 86 · standardAP
1984-10-22Manufacturing (CMC) · Supplement 83 · 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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