← FDA DRUG APPROVALS

FDA NDA · NDA016679

LACTATED RINGERS AND DEXTROSE

sodium chloride, sodium lactate, potassium chloride, calcium chloride and dextrose monohydrate

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA016679
TYPE
NDA
ORIGINAL APPROVAL
1971-03-22
LATEST ACTION
2025-11-05
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINERPrescription
CALCIUM CHLORIDE 20MG/100ML, DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 30MG/100ML, SODIUM CHLORIDE 600MG/100ML, SODIUM LACTATE 310MG/100ML · INJECTABLE · INJECTION

Approval history

2025-11-05Labeling · Supplement 122 · standard — Label ↗AP
2019-10-09Labeling · Supplement 114 · standard — Letter ↗AP
2017-12-06Labeling · Supplement 108 · standard — Letter ↗AP
2016-01-19Manufacturing (CMC) · Supplement 111 · standardAP
2015-02-03Manufacturing (CMC) · Supplement 110 · standardAP
2014-09-30Manufacturing (CMC) · Supplement 109 · standardAP
2013-11-06Manufacturing (CMC) · Supplement 106 · standardAP
2013-04-26Manufacturing (CMC) · Supplement 107 · standardAP
2011-10-19Labeling · Supplement 104 · unknown — Letter ↗AP
2004-05-12Labeling · Supplement 96 · standard — Letter ↗AP
2001-08-14Manufacturing (CMC) · Supplement 94 · standardAP
2000-11-29Labeling · Supplement 91 · standardAP
2000-11-02Labeling · Supplement 93 · standardAP
1999-11-24Manufacturing (CMC) · Supplement 92 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 90 · standardAP
1996-10-11Manufacturing (CMC) · Supplement 89 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 87 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 88 · standardAP
1991-04-29Manufacturing (CMC) · Supplement 85 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 84 · standardAP
1991-02-15Manufacturing (CMC) · Supplement 82 · standardAP
1991-01-10Manufacturing (CMC) · Supplement 83 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 81 · standardAP
1987-07-25Manufacturing (CMC) · Supplement 80 · standardAP
1987-05-28Manufacturing (CMC) · Supplement 79 · standardAP
1986-02-27Manufacturing (CMC) · Supplement 77 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 68 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 69 · standardAP
1985-07-03Labeling · Supplement 74AP
1985-06-13Manufacturing (CMC) · Supplement 73 · standardAP
1985-04-15Manufacturing (CMC) · Supplement 76 · standardAP
1985-01-24Manufacturing (CMC) · Supplement 66 · standardAP
1984-09-22Manufacturing (CMC) · Supplement 72 · standardAP
1984-03-16Manufacturing (CMC) · Supplement 67 · standardAP
1984-02-28Manufacturing (CMC) · Supplement 71 · standardAP
1983-07-11Labeling · Supplement 63AP
1982-06-03Manufacturing (CMC) · Supplement 60 · standardAP
1982-04-16Manufacturing (CMC) · Supplement 58 · standardAP
1982-02-16Manufacturing (CMC) · Supplement 64 · standardAP
1981-12-21Manufacturing (CMC) · Supplement 55 · standardAP
VIEW ON DRUGS@FDA ↗

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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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