APPLICATION
NDA017635
TYPE
NDA
ORIGINAL APPROVAL
1976-05-14
LATEST ACTION
2014-06-12
ROUTE
IRRIGATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
RINGER'S IN PLASTIC CONTAINERPrescription
CALCIUM CHLORIDE 33MG/100ML, POTASSIUM CHLORIDE 30MG/100ML, SODIUM CHLORIDE 860MG/100ML · SOLUTION · IRRIGATION
Approval history
2014-06-12Manufacturing (CMC) · Supplement 57 · standardAP
2000-02-28Labeling · Supplement 45 · standardAP
1999-12-01Manufacturing (CMC) · Supplement 46 · standardAP
1998-02-04Manufacturing (CMC) · Supplement 44 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 43 · standardAP
1993-08-24Manufacturing (CMC) · Supplement 40 · standardAP
1992-06-30Manufacturing (CMC) · Supplement 41 · standardAP
1988-12-27Manufacturing (CMC) · Supplement 39 · standardAP
1986-02-25Manufacturing (CMC) · Supplement 30 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 38 · standardAP
1986-01-18Manufacturing (CMC) · Supplement 35 · standardAP
1985-10-29Manufacturing (CMC) · Supplement 37 · standardAP
1984-11-09Manufacturing (CMC) · Supplement 34 · standardAP
1984-10-22Manufacturing (CMC) · Supplement 33 · standardAP
1984-08-25Manufacturing (CMC) · Supplement 31 · standardAP
1984-03-15Manufacturing (CMC) · Supplement 29 · standardAP
1984-03-01Manufacturing (CMC) · Supplement 27 · standardAP
1982-08-31Labeling · Supplement 24AP
1982-06-18Manufacturing (CMC) · Supplement 28 · standardAP
1982-06-10Manufacturing (CMC) · Supplement 26 · standardAP
1981-11-06Manufacturing (CMC) · Supplement 25 · standardAP
1981-07-21Manufacturing (CMC) · Supplement 15 · standardAP
1980-09-30Manufacturing (CMC) · Supplement 23 · standardAP
1980-09-25Labeling · Supplement 22AP
1980-06-06Manufacturing (CMC) · Supplement 19 · standardAP
1980-06-06Manufacturing (CMC) · Supplement 21 · standardAP
1980-05-28Manufacturing (CMC) · Supplement 17 · standardAP
1980-05-23Manufacturing (CMC) · Supplement 18 · standardAP
1980-05-16Labeling · Supplement 16AP
1980-03-20Manufacturing (CMC) · Supplement 14 · standardAP
1980-02-12Manufacturing (CMC) · Supplement 13 · standardAP
1979-10-04Manufacturing (CMC) · Supplement 10 · standardAP
1979-07-31Manufacturing (CMC) · Supplement 9 · standardAP
1979-07-18Manufacturing (CMC) · Supplement 8 · standardAP
1979-05-01Manufacturing (CMC) · Supplement 5 · standardAP
1979-02-02Labeling · Supplement 6AP
1979-01-05Manufacturing (CMC) · Supplement 7 · standardAP
1978-08-29Manufacturing (CMC) · Supplement 4 · standardAP
1977-07-21Manufacturing (CMC) · Supplement 2 · standardAP
1977-04-26Manufacturing (CMC) · Supplement 3 · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.