← FDA DRUG APPROVALS
FDA NDA · NDA018251
RINGERS
sodium chloride, potassium chloride, and calcium chloride
Sponsor: OTSUKA ICU MEDCL
APPLICATION
NDA018251
TYPE
NDA
ORIGINAL APPROVAL
1980-05-16
LATEST ACTION
2026-03-24
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
RINGER'S IN PLASTIC CONTAINERPrescription
CALCIUM CHLORIDE 33MG/100ML, POTASSIUM CHLORIDE 30MG/100ML, SODIUM CHLORIDE 860MG/100ML · INJECTABLE · INJECTION
Approval history
2014-09-08Manufacturing (CMC) · Supplement 89 · standardAP
1999-10-28Labeling · Supplement 70AP
1999-10-12Labeling · Supplement 66AP
1998-12-01Manufacturing (CMC) · Supplement 68 · standardAP
1997-06-11Manufacturing (CMC) · Supplement 67 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 63 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 62 · standardAP
1996-08-06Manufacturing (CMC) · Supplement 65 · standardAP
1996-03-04Manufacturing (CMC) · Supplement 64 · standardAP
1995-08-14Manufacturing (CMC) · Supplement 61 · standardAP
1992-01-28Manufacturing (CMC) · Supplement 57 · standardAP
1991-09-10Manufacturing (CMC) · Supplement 56 · standardAP
1991-08-30Manufacturing (CMC) · Supplement 58 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 53 · standardAP
1990-01-11Manufacturing (CMC) · Supplement 54 · standardAP
1989-06-22Manufacturing (CMC) · Supplement 29 · standardAP
1987-07-30Manufacturing (CMC) · Supplement 50 · standardAP
1986-11-26Manufacturing (CMC) · Supplement 49 · standardAP
1986-08-08Manufacturing (CMC) · Supplement 48 · standardAP
1986-02-25Manufacturing (CMC) · Supplement 30 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 47 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 44 · standardAP
1985-11-29Manufacturing (CMC) · Supplement 32 · standardAP
1985-11-29Labeling · Supplement 33AP
1985-10-29Manufacturing (CMC) · Supplement 31 · standardAP
1985-10-26Manufacturing (CMC) · Supplement 40 · standardAP
1985-10-26Labeling · Supplement 42AP
1985-09-26Manufacturing (CMC) · Supplement 35 · standardAP
1985-06-10Manufacturing (CMC) · Supplement 46 · standardAP
1985-05-03Manufacturing (CMC) · Supplement 41 · standardAP
1984-11-09Manufacturing (CMC) · Supplement 39 · standardAP
1984-10-22Manufacturing (CMC) · Supplement 36 · standardAP
1984-10-17Manufacturing (CMC) · Supplement 26 · standardAP
1984-10-10Manufacturing (CMC) · Supplement 22 · standardAP
1984-10-10Labeling · Supplement 23AP
1984-04-09Manufacturing (CMC) · Supplement 28 · standardAP
1984-03-21Manufacturing (CMC) · Supplement 25 · standardAP
1984-03-01Manufacturing (CMC) · Supplement 20 · standardAP
1983-12-08Manufacturing (CMC) · Supplement 24 · 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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